Cardiovascular DiseasesPhase 2DEFINENCT03449251
A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin
A Phase 2 study testing Apelin, Relaxin and Normal saline in people with Cardiovascular Diseases and Type 2 Diabetes Mellitus, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Type 2 Diabetes Mellitus
- What is being tested?
- Apelin, Relaxin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2018to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy participants
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
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- BMI in range for studies 1 and 4: 18.5-24.9 kg/m2 with waist circumference lower than 88 centimetres (35 inches) for women or 102 cm (40 inches) for men, and/or body fat level less than 32 % for women or 25% for men
- BMI in range for studies 2 and 3: 18.5-30.0 kg/m2 without limitations in waist circumference or body fat level
- Overweight/obese participants
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
- BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
- Participants with type 2 diabetes mellitus
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
- If female, either postmenopausal or on days 2-9 of menstrual cycle and negative pregnancy test performed on the day of the of visit
- BMI in range of 25-34.9 kg/m2 (inclusive) with either waist circumference higher than 88cm (35 inches) for women or 102 cm (40 inches) for men, and/or body fat levels in excess of 32% for women or 25% for men
- Documented diagnosis of Type 2 Diabetes Mellitus, either diet controlled or treated with oral hypoglycaemic therapy
Who cannot join
- Hypersensitivity to any of the study drugs or excipients
- Systemic Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
- Known heart disease
- Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
- Known renal failure (creatinine >140µmol/L)
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- Known neurological disease
- History of Scleroderma (Study 4 only)
- Current pregnancy, breast feeding
- Use of vasoactive medications or NSAIDS/aspirin within 24 hours of study visits
- Use of caffeine within 24 hours of study visits
- Current involvement in the active treatment phase of other research studies, (excluding observations/non-interventional)
- Second or third-degree AV block, sino-atrial block, sick sinus syndrome or sinus bradycardia
- Known HIV, hepatitis B or C
- Needle phobia
- Participants treated with formal anticoagulant therapy such as, but not limited to, heparin, warfarin or clopidogrel
- Diagnosis of Type 1 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP1 agonists
- BMI <18.5
- Aged <18 or >70 years
- Any other clinical reason which may preclude entry in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ
About this study
Official title: A Series of Pilot Studies to Evaluate the Haemodynamic and Metabolic Effects of Apelin and Relaxin in Healthy Humans, Subjects With Increased Weight and Patients With Type 2 Diabetes Mellitus
Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications.
Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.
Read the detailed description
An extensive body of evidence demonstrates a direct association between T2DM and cardiovascular complications and mortality. Unfortunately, current therapies for diabetes have failed to be translated into improvements in cardiovascular outcomes, highlighting an urgent need to develop novel therapeutic strategies that can ultimately achieve the dual outcome of improving glycaemic control and improving cardiovascular function.
While the precise cellular mechanisms involved remain to be elucidated, we hypothesise that the apelin and relaxin pathways meet these two criteria and therefore are potential therapeutic targets in conditions of abnormal glucose metabolism and heart failure.
Apelin and relaxin are safe for parenteral use as they are naturally occurring peptide hormones, have a short half-life and will be rapidly cleared. They target endogenous receptors and post-receptor signalling, and have been used in human trials without any significant side effects reported.
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes Mellitus
- Being tested
- Apelin, Relaxin, Normal saline, Verapamil, LN Monomethyl arginine
- Keywords
- Apelin, Relaxin
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApelinDrug
Apelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.
RelaxinDrug
Also called RLX
Relaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.
Normal salineDrug
Also called Saline
Vehicle
VerapamilDiagnostic test
NO independent challenge agent
LN Monomethyl arginineDiagnostic test
Also called LNMMA
Basal NO synthase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Substudy 1A - Apelin | Experimental | In sub-study 1A Healthy participants will receive systemic infusions of Apelin to establish a dose range Receives: Drug: Apelin |
| Substudy 1B - Apelin/Normal Saline | Experimental | In sub-study 1B , individuals with Type 2 Diabetes and individuals with increase weight will receive systemic infusions of Apelin or Normal Saline Receives: Drug: Apelin; Drug: Normal saline |
| Substudy 2A - Relaxin/Normal Saline | Experimental | In sub-study 2A Healthy participants will receive intra-arterial infusions of Relaxin Receives: Drug: Relaxin; Drug: Normal saline |
| Substudy 2B - Relaxin | Experimental | In sub-study 2B Healthy participants will receive intra-arterial infusions of Relaxin followed by verapamil (on a background infusion of either LN Monomethyl Arginine or Normal Saline, to test effects on nitric oxide) Receives: Drug: Relaxin; Diagnostic Test: Verapamil; Diagnostic Test: LN Monomethyl arginine |
| Substudy 3A - Relaxin with Apelin/Saline | Experimental | In sub-study 3A Healthy participants will receive intra-arterial infusions of Relaxin (background infusion apelin/Normal Saline) Receives: Drug: Apelin; Drug: Relaxin; Drug: Normal saline |
| Substudy 3B - Apelin with Relaxin/Saline | Experimental | In sub-study 3B Healthy participants will receive intra-arterial infusions of Apelin (background infusion Relaxin/Normal Saline) Receives: Drug: Apelin; Drug: Relaxin; Drug: Normal saline |
| Substudy 4 - Apelin and Relaxin | Experimental | In sub-study 4 Healthy participants, Individuals with Type 2 Diabetes and Individuals with increase weight will receive systemic infusions of Normal saline, Relaxin, Apelin and relaxin Receives: Drug: Apelin; Drug: Relaxin |
| Substudy 5 - Relaxin/Saline | Experimental | In sub-study 5 Healthy participants will be allocated to 1 of 4 Relaxin dosing groups and will receive dorsal hand vein infusion of 3 incremental doses of Normal Saline/ D5W and Relaxin Receives: Drug: Relaxin; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucose)
Glucose, in mmol/l
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (C-Peptide)
C-peptide, in pmol/L
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucagon)
Glucagon, in pg/ml
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Insulin)
Insulin, in pmol/L
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (TNF-alpha)
TNF-alpha, in pg/ml
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Glucose, in mmol/l
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
C-peptide, in pmol/L
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Glucagon, in pg/ml
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Insulin, in pmol/L
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
TNF-alpha, in pg/ml
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Absolute Flow)
Absolute flow in the infused arm, in mg/dL/min
Measured: Within visit 2, over a period of up to 4 weeks
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Percentage Change)
Percentage change in the infused arm, in %
Measured: Within visit 2, over a period of up to 4 weeks
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: Within visit 2, over a period of up to 4 weeks
Sub-study 2b: Change in forearm blood flow parameters in healthy participants after infusion of relaxin in the presence of L-NMMA or normal saline
Ratio; absolute flow and percentage change in the infused arm
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Ratio)
Ratio; expressed as a number (no units as this is a ratio)
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Absolute Flow)
Absolute flow in the infused arm, in mg/dL/min
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Percentage Change)
Percentage change in the infused arm, In %
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin
Ratio; absolute flow and percentage change in the infused arm
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Absolute Flow)
Absolute flow in the infused arm, in mg/dL/min
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Percentage Change)
Percentage change in the infused arm, In %
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Absolute Flow)
Absolute flow in the infused arm, in mg/dL/min
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Percentage Change)
Percentage change in the infused arm, In %
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucose)
Glucose, in each of the groups, in mmol/L
Measured: Visit 2 to Visit 4, over a period of up to 8 weeks
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (C-peptide)
C-peptide, in each of the groups, in pmol/L
Measured: Visit 2 to Visit 4, over a period of up to 8 weeks
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucagon)
glucagon, in each of the groups,in pg/ml
Measured: Visit 2 to Visit 4, over a period of up to 8 weeks
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Insulin)
Insulin, in each of the groups, in pmol/L
Measured: Visit 2 to Visit 4, over a period of up to 8 weeks
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (TNF-alpha)
TNF-alpha, in each of the groups, in pg/ml
Measured: Visit 2 to Visit 4, over a period of up to 8 weeks
Sub-study 5: Change in hand vein diameter after relaxin infusion in healthy participants
Hand vein Demeter is measured using Aellig dorsal hand vein technique
Measured: Visit 2
Secondary outcomes (28)
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Echocardiography)
Cardiac output measured by Echocardiography, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Innocor)
Cardiac output measured by Innocor, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Bioimpedance)
Cardiac output measured by bioimpedance, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Echocardiography)
Cardiac output measured by Echocardiography, in L/min
Measured: VIsit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Innocor)
Cardiac output measured by Innocor, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Bioimpedance)
Cardiac output measured by bioimpedance, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Echocardiography)
Cardiac output measured by Echocardiography, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin, after a mixed meal challenge (Innocor)
Cardiac output measured by Innocor, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Bioimpedance)
Cardiac output measured by bioimpedance, in L/min
Measured: VIsit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Clugose)
Glucose, in mmol/L
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (C-peptide)
C-peptide, in pmol/L
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Glucagon)
Glucagon, in pg/ml
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Insulin)
Insulin, in pmol/L
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (TNF alpha)
TNF alpha, in pg/ml
Measured: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Ratio)
Ratio,expressed as a number (no units as this is a ratio)
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Absolute Flow)
Absolute flow in the infused arm, in mg/dL/min
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Percentage Change)
Percentage change in the infused arm, In %
Measured: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Echocardiography)
Cardiac output measured by Echocardiography, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Bioimpedance)
Cardiac output measured by bioimpedance, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Innocor)
Cardiac output measured by Innocor, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Echocardiography)
Cardiac output measured by Echocardiography, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Bioimpedance)
Cardiac output measured by bioimpedance, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Innocor)
Cardiac output measured by Innocor, in L/min
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucose)
Glucose, in mmol/L
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (C-peptide)
C-peptide, in pmol/L
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucagon)
Glucagon, in pg/ml
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Insulin)
Insulin, in pmol/L
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (TNF alpha)
TNF alpha, glucose homeostasis
Measured: Visit 2 to visit 4, over a period of up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start28 Mar 2018
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, AstraZeneca, MedImmune LLC
- Responsible party
- Principal investigator, Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBCHB, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449251
- Sponsor's protocol ID
- DEFINE (A094666)
- Acronym
- DEFINE
- Status last verified
- Sep 2026
- First submitted
- 6 Feb 2018
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Series of Pilot Studies to Evaluate the Haemodynamic and Metabolic Effects of Apelin and Relaxin in Healthy Humans, Subjects With Increased Weight and Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03449251
- Acronym / sponsor ID
- DEFINE / DEFINE (A094666)
- Conditions
- Cardiovascular Diseases, Type 2 Diabetes Mellitus
- Keywords
- Apelin, Relaxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, AstraZeneca, MedImmune LLC
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type two diabetes mellitus (T2DM) is a common, long term metabolic disorder characterised by hyperglycaemia (high blood glucose) resulting from insulin resistance and relative insulin insufficiency. The risk of developing insulin resistance and subsequently T2DM is increased by being overweight and also through a sedentary lifestyle. As the onset can be gradual, physiological damage may have occurred prior to diagnosis. Diabetes is associated with the development of microvascular complications (diabetic nephropathy, neuropathy, and retinopathy), and macrovascular complications (coronary artery disease, peripheral arterial disease, and stroke). While there are many treatments available for T2DM, these complications may still arise, leading to significant morbidity and mortality. There is therefore an urgent need to identify novel signalling pathways that may contribute to the development of diabetes related complications. The identification of these pathways may ultimately lead to the development of new therapies targeting better blood glucose control and preventing these subsequent complications.
Both animal and human studies have indicated that two endogenous peptides, apelin and relaxin both act as vasodilators in the human cardiovascular system and could also have beneficial action in T2DM. Therefore, we aim to carry out experimental medicine studies to test this hypothesis, and explore the signalling pathway in the human vascular system.
Detailed description
An extensive body of evidence demonstrates a direct association between T2DM and cardiovascular complications and mortality. Unfortunately, current therapies for diabetes have failed to be translated into improvements in cardiovascular outcomes, highlighting an urgent need to develop novel therapeutic strategies that can ultimately achieve the dual outcome of improving glycaemic control and improving cardiovascular function.
While the precise cellular mechanisms involved remain to be elucidated, we hypothesise that the apelin and relaxin pathways meet these two criteria and therefore are potential therapeutic targets in conditions of abnormal glucose metabolism and heart failure.
Apelin and relaxin are safe for parenteral use as they are naturally occurring peptide hormones, have a short half-life and will be rapidly cleared. They target endogenous receptors and post-receptor signalling, and have been used in human trials without any significant side effects reported.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Substudy 1A - Apelin | Experimental | Drug: ApelinIn sub-study 1A Healthy participants will receive systemic infusions of Apelin to establish a dose range |
| Substudy 1B - Apelin/Normal Saline | Experimental | Drug: Apelin, Drug: Normal salineIn sub-study 1B , individuals with Type 2 Diabetes and individuals with increase weight will receive systemic infusions of Apelin or Normal Saline |
| Substudy 2A - Relaxin/Normal Saline | Experimental | Drug: Relaxin, Drug: Normal salineIn sub-study 2A Healthy participants will receive intra-arterial infusions of Relaxin |
| Substudy 2B - Relaxin | Experimental | Drug: Relaxin, Diagnostic Test: Verapamil, Diagnostic Test: LN Monomethyl arginineIn sub-study 2B Healthy participants will receive intra-arterial infusions of Relaxin followed by verapamil (on a background infusion of either LN Monomethyl Arginine or Normal Saline, to test effects on nitric oxide) |
| Substudy 3A - Relaxin with Apelin/Saline | Experimental | Drug: Apelin, Drug: Relaxin, Drug: Normal salineIn sub-study 3A Healthy participants will receive intra-arterial infusions of Relaxin (background infusion apelin/Normal Saline) |
| Substudy 3B - Apelin with Relaxin/Saline | Experimental | Drug: Apelin, Drug: Relaxin, Drug: Normal salineIn sub-study 3B Healthy participants will receive intra-arterial infusions of Apelin (background infusion Relaxin/Normal Saline) |
| Substudy 4 - Apelin and Relaxin | Experimental | Drug: Apelin, Drug: RelaxinIn sub-study 4 Healthy participants, Individuals with Type 2 Diabetes and Individuals with increase weight will receive systemic infusions of Normal saline, Relaxin, Apelin and relaxin |
| Substudy 5 - Relaxin/Saline | Experimental | Drug: Relaxin, Drug: Normal salineIn sub-study 5 Healthy participants will be allocated to 1 of 4 Relaxin dosing groups and will receive dorsal hand vein infusion of 3 incremental doses of Normal Saline/ D5W and Relaxin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Healthy participants
- Have given written informed consent to participate
- Aged 18 to 70 years inclusive
- Male or female
- Current non-smoker
Key exclusion criteria (20 listed)
- Hypersensitivity to any of the study drugs or excipients
- Systemic Hypertension (sustained BP >160/100mmHg) or hypotension (systolic BP below 90 mmHg)
- Known heart disease
- Implanted heart pace-maker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApelinApelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity. | Drug | Substudy 1A - Apelin, Substudy 1B - Apelin/Normal Saline, Substudy 3A - Relaxin with Apelin/Saline, Substudy 3B - Apelin with Relaxin/Saline, Substudy 4 - Apelin and Relaxin |
| RelaxinAlso: RLXRelaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1. | Drug | Substudy 2A - Relaxin/Normal Saline, Substudy 2B - Relaxin, Substudy 3A - Relaxin with Apelin/Saline, Substudy 3B - Apelin with Relaxin/Saline, Substudy 4 - Apelin and Relaxin, Substudy 5 - Relaxin/Saline |
| Normal salineAlso: SalineVehicle | Drug | Substudy 1B - Apelin/Normal Saline, Substudy 2A - Relaxin/Normal Saline, Substudy 3A - Relaxin with Apelin/Saline, Substudy 3B - Apelin with Relaxin/Saline, Substudy 5 - Relaxin/Saline |
| VerapamilNO independent challenge agent | Diagnostic test | Substudy 2B - Relaxin |
| LN Monomethyl arginineAlso: LNMMABasal NO synthase inhibitor | Diagnostic test | Substudy 2B - Relaxin |
Primary outcome
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucose)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Glucose, in mmol/l
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (C-Peptide)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
C-peptide, in pmol/L
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucagon)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Glucagon, in pg/ml
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Insulin)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Insulin, in pmol/L
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (TNF-alpha)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
TNF-alpha, in pg/ml
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Glucose, in mmol/l
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
C-peptide, in pmol/L
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Glucagon, in pg/ml
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Insulin, in pmol/L
Sub-study 1b: Changes in markers of glucose homeostasis in participants with increased weight and participants with type 2 diabetes mellitus after infusion of apelin with or without mixed meal tolerance in obese/overweight and T2DM participants
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
TNF-alpha, in pg/ml
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Absolute Flow)
Time frame: Within visit 2, over a period of up to 4 weeks
Absolute flow in the infused arm, in mg/dL/min
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Percentage Change)
Time frame: Within visit 2, over a period of up to 4 weeks
Percentage change in the infused arm, in %
Sub-study 2a: Change in forearm blood flow parameters in healthy participants after infusion of relaxin (Ratio)
Time frame: Within visit 2, over a period of up to 4 weeks
Ratio, expressed as a number (no units as this is a ratio)
Sub-study 2b: Change in forearm blood flow parameters in healthy participants after infusion of relaxin in the presence of L-NMMA or normal saline
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Ratio; absolute flow and percentage change in the infused arm
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Ratio)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Ratio; expressed as a number (no units as this is a ratio)
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Absolute Flow)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Absolute flow in the infused arm, in mg/dL/min
Sub-study 2b: Change in forearm blood flow parameters in health participants after infusion of verapamil in the presence of L-NMMA or normal saline (Percentage Change)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Percentage change in the infused arm, In %
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Ratio; absolute flow and percentage change in the infused arm
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Ratio)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Ratio, expressed as a number (no units as this is a ratio)
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Absolute Flow)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Absolute flow in the infused arm, in mg/dL/min
Sub-Study 3a: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial relaxin in the presence of apelin (Percentage Change)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Percentage change in the infused arm, In %
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Ratio)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Ratio, expressed as a number (no units as this is a ratio)
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Absolute Flow)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Absolute flow in the infused arm, in mg/dL/min
Sub-Study 3b: Change in forearm blood flow parameters in healthy participants after incremental infusions of intra-arterial apelin in the presence of relaxin (Percentage Change)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Percentage change in the infused arm, In %
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucose)
Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks
Glucose, in each of the groups, in mmol/L
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (C-peptide)
Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks
C-peptide, in each of the groups, in pmol/L
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Glucagon)
Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks
glucagon, in each of the groups,in pg/ml
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (Insulin)
Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks
Insulin, in each of the groups, in pmol/L
Sub-study 4: Changes in markers of glucose homeostasis healthy participants, participants with increased weight and participants with type 2 diabetes mellitus after infusion of relaxin with and without apelin (TNF-alpha)
Time frame: Visit 2 to Visit 4, over a period of up to 8 weeks
TNF-alpha, in each of the groups, in pg/ml
Sub-study 5: Change in hand vein diameter after relaxin infusion in healthy participants
Time frame: Visit 2
Hand vein Demeter is measured using Aellig dorsal hand vein technique
28 secondary outcomes
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Echocardiography)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Innocor)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1a: Changes in parameters of cardiovascular haemodynamics in healthy participants after infusion of apelin (Bioimpedance)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Echocardiography)
Time frame: VIsit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Innocor)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin (Bioimpedance)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Echocardiography)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin, after a mixed meal challenge (Innocor)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in parameters of cardiovascular haemodynamics in obese/overweight and T2DM participants after infusion of apelin,after a mixed meal challenge (Bioimpedance)
Time frame: VIsit 2 to visit 4, over a period of up to 8 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Clugose)
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (C-peptide)
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Glucagon)
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (Insulin)
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 1b: Changes in markers of glucose homeostasis after infusion of apelin in obese/overweight and T2DM, after a mixed meal challenge (TNF alpha)
Time frame: Visit 2 to visit 5, over a period of up to 14 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Ratio)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Absolute Flow)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 2b: Change in forearm blood flow parameters after infusion of verapamil in the presence of L-NMMA or saline (Percentage Change)
Time frame: Visit 2 to visit 3, over a period of up to 10 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Echocardiography)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Bioimpedance)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after infusion of relaxin (Innocor)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Echocardiography)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Bioimpedance)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in cardiovascular haemodynamics after combined infusion of relaxin and apelin (Innocor)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucose)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Substudy 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (C-peptide)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Glucagon)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (Insulin)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Sub-study 4: Change in glucose homeostasis after combined infusion of relaxin and apelin (TNF alpha)
Time frame: Visit 2 to visit 4, over a period of up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheriyan, MBCHB, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apelin, Relaxin and Normal saline in people with Cardiovascular Diseases and Type 2 Diabetes Mellitus, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-study 1a: Changes in markers of glucose homeostasis in healthy participants after infusion of apelin (Glucose) (time frame: Visit 2 to visit 4, over a period of up to 8 weeks). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.