Cardiovascular DiseasesPhase 4DECODENCT07483801
DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies
A Phase 4 study testing semaglutide and Tirzepatide in people with Cardiovascular Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- semaglutide and Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2026to Apr 2028
- Phase
- Phase 4
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion Criteria - Participants with normal weight and normal blood pressure
- Have given written informed consent to participate
- Aged 18 to 50 years (inclusive)
- Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have a negative pregnancy test (performed at each visit)
- Current non-smoker
- Body mass index (BMI) in range 18.5-24.9 kg/m2
Show all 23Show fewer
- Clinic brachial systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
- Inclusion Criteria - Obese participants with normal blood pressure
- Have given written informed consent to participate
- Aged 18 to 50 years (inclusive)
- Male or female
- Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit)
- Current non-smoker
- BMI ≥30 kg/m2
- Clinic brachial systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg
- Inclusion Criteria - Obese participants with high blood pressure
- Have given written informed consent to participate
- Aged 18 to 50 years (inclusive)
- Male or female
- Females must be post/peri-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit)
- Current non-smoker
- BMI ≥30 kg/m2
- Diagnosis of stage 1 essential hypertension
Who cannot join
- Regular use of medications with vasoactive or cardiac effects in normotensive individuals; inability or unwillingness to omit anti-hypertensive medications on the morning of the study visits in hypertensive individuals
- Hypersensitivity to any of the study drugs or excipients
- Known clinically significant valvular heart disease
- Implanted pacemaker or implantable cardioverter defibrillator (ICD)
- Known active malignancy
- Known renal impairment (creatinine >150µmol/L)
Show all 23Show fewer
- Clinically significant neurological disease
- History of scleroderma
- Current pregnancy, breastfeeding
- Current involvement in the active treatment phase of other research studies (excluding observational/non-interventional)
- Second or third-degree AV block, sino-atrial block, sick sinus syndrome
- Known HIV, hepatitis B or C
- Needle phobia
- Participants treated with formal anticoagulant therapy such as, but not limited to, heparin or warfarin
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists
- BMI <18.5 kg/m2
- Known heart failure
- Currently taking drugs likely to have interactions with semaglutide or tirzepatide
- Family history of multiple endocrine neoplasia
- Known thyroid cancer
- Known history of pancreatitis
- History of gall stones (unless the gall bladder has been removed)
- Any other clinical reason which may preclude entry in the opinion of the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ
Joseph Cheriyan, MBChB, MA, FRCP, 01223256653, jc403@cam.ac.uk
Joseph Cheriyan, MBChB, MA, FRCP
About this study
What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels.
There are three different populations being looked at for this study: participants with normal weight and normal blood pressure, participants with obesity and normal blood pressure, and participants with obesity and high blood pressure.
There are six sub-studies each with different visit schedules. The minimum participant study duration (including follow-up phone call) would be 2 days, while the maximum participant study duration would be approximately 2 - 2.5 months. The overall study duration is expected to be approximately 18 months.
Read the detailed description
High blood pressure (hypertension) is the leading risk factor for death globally. It affects approximately 30% of adults in the United Kingdom. Obesity is also serious, ongoing epidemic. Hypertension and obesity share a well-known association, but despite extensive research, the mechanisms underlying their association are still poorly understood. Approximately 50% of all hypertensive cases are linked to obesity, with an even greater proportion in young adults. Since one of the most common causes of high blood pressure is overweight or obesity, a healthy diet and weight loss are recommended for patients with stage 1 hypertension (clinic blood pressure ranging from 140/90 mmHg to 159/99 mmHg) before initiating blood pressure-lowering medications. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not maintained in the majority of cases. Therefore, further weight loss interventions could play a crucial role in the treatment of obesity and obesity-related hypertension.
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones with a variety of physiological actions. Their metabolic effects in the pancreas, stimulating glucose-dependent insulin secretion have led to the development of medications acting on these GLP-1 and GIP receptors for the treatment of type 2 diabetes mellitus, which are now well established. These new medications cause significant weight loss in adults with obesity and/or diabetes and are well tolerated. Beyond the substantial weight loss caused by these drugs, blood pressure also decreased significantly according to recent large studies. The blood pressure-lowering effect of these drugs may significantly contribute to the improved cardiovascular outcomes observed in previous large trials and analyses. Accordingly, these drugs could play a very important role in the treatment of hypertensive individuals with obesity. Whilst much of the blood pressure reduction elicited by these drugs could be mediated by the weight loss (~70% in recent trials), it is also possible based on previous experiments performed in animal models as well as human subjects that these drugs exert direct effects on the cardiovascular system.
The current study will examine the direct cardiovascular effects of the GLP-1 analogue semaglutide and the dual GIP/GLP-1 receptor agonist tirzepatide using two approaches: (i) investigation of the function of blood vessels in response to locally-acting infusions of semaglutide and tirzepatide into the forearm artery, and (ii) investigation of systemic effects [blood pressure, heart rate, cardiac output (amount of blood pumped by the heart per minute), vascular resistance] of semaglutide and tirzepatide in response to systemically-acting intravenous infusions.
- Conditions
- Cardiovascular Diseases
- Being tested
- semaglutide, Tirzepatide
- Keywords
- Metabolic, Endocrine, Semaglutide, tirzepatide, weight loss, hypertension)
- Medical subject headings
- Cardiovascular Diseases, Weight Loss, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Semaglutide: GLP-1 analogue
TirzepatideDrug
Tirzepatide: dual GIP/GLP-1 receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1A | Experimental | Intra-arterial infusion of semaglutide Receives: Drug: semaglutide |
| Sub-study 1B | Experimental | Intra-arterial infusion of Tirzepatide Receives: Drug: Tirzepatide |
| Sub-study 1C | Experimental | Intra-arterial infusion of Saline, Semaglutide and Tirzepatide Receives: Drug: semaglutide; Drug: Tirzepatide |
| Sub-study 2A | Experimental | Slow intravenous bolus of Semaglutide Receives: Drug: semaglutide |
| Sub-study 2B | Experimental | Slow intravenous bolus of Tirzepatide Receives: Drug: Tirzepatide |
| Sub-study 2C | Experimental | Slow intravenous bolus of Semaglutide and Tirzepatide Receives: Drug: semaglutide; Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: 2-2.5 months from screening to follow-up
Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Absolute flow)
Absolute flow in the infused arm, in mL/min/100 mL
Measured: 2-2.5 months from screening to follow-up
Sub-study 1A: Change in forearm blood flow parameters after infusion of semaglutide (Percentage Change)
Percentage change in the infused arm, in %
Measured: 2-2.5 months from screening to follow-up
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Absolute flow)
Absolute flow in the infused arm, in mL/min/100 mL
Measured: 2-2.5 months from screening to follow-up
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: 2-2.5 months from screening to follow-up
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Percent Change)
Percentage change in the infused arm, in %
Measured: 2-2.5 months from screening to follow-up
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Absolute flow)
Absolute flow in the infused arm, in mL/min/100 mL
Measured: 2-2.5 months from screening to follow-up
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Ratio)
Ratio, expressed as a number (no units as this is a ratio)
Measured: 2-2.5 months from screening to follow-up
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Percentage change)
Percentage change in the infused arm, in %
Measured: 2-2.5 months from screening to follow-up
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Blood pressure)
Blood pressure measured in mmHg
Measured: 2-2.5 months from screening to follow-up
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Heart rate)
Heart rate measured in beats per minute (bpm)
Measured: 2-2.5 months from screening to follow-up
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Cardiac output)
Cardiac output measured in L/min
Measured: 2-2.5 months from screening to follow-up
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Vascular resistance)
Vascular resistance measured in dynes⋅sec⋅cm5
Measured: 2-2.5 months from screening to follow-up
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Blood pressure)
Blood pressure measured in mmHg
Measured: 2-2.5 months from screening to follow-up
Sub-study 2B: Changes in cardiovascular haemodynamic variables ) after administration of tirzepatide (Heart rate)
Heart rate measured in beats per minute (bpm)
Measured: 2-2.5 months from screening to follow-up
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Cardiac output)
Cardiac output measured in L/min
Measured: 2-2.5 months from screening to follow-up
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Vascular resistance)
Vascular resistance measured in dynes⋅sec⋅cm5
Measured: 2-2.5 months from screening to follow-up
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Blood pressure)
Blood pressure measured in mmHg
Measured: 2-2.5 months from screening to follow-up
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Heart rate)
Heart rate measured in beats per minute (bpm)
Measured: 2-2.5 months from screening to follow-up
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Cardiac output)
Cardiac output measured in L/min
Measured: 2-2.5 months from screening to follow-up
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Vascular resistance)
Vascular resistance measured in dynes⋅sec⋅cm5
Measured: 2-2.5 months from screening to follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Cheriyan, MBChB, MA, FRCP, FESC, FACC, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483801
- Sponsor's protocol ID
- DECODE (A097165)
- Acronym
- DECODE
- Status last verified
- Mar 2026
- First submitted
- 3 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Access to IPD may be granted if a prospective applicant submits a request. The request will be reviewed by the sponsor and the Chief Investigator, and access will be approved only where there are clear academic reasons to allow use of the data. An IPD sharing plan will be discussed and relevant data sharing agreements will be developed when required.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies
- ClinicalTrials.gov ID
- NCT07483801
- Acronym / sponsor ID
- DECODE / DECODE (A097165)
- Conditions
- Cardiovascular Diseases
- Keywords
- Metabolic, Endocrine, Semaglutide, tirzepatide, weight loss, hypertension)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 19 Mar 2026 (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.
What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels.
There are three different populations being looked at for this study: participants with normal weight and normal blood pressure, participants with obesity and normal blood pressure, and participants with obesity and high blood pressure.
There are six sub-studies each with different visit schedules. The minimum participant study duration (including follow-up phone call) would be 2 days, while the maximum participant study duration would be approximately 2 - 2.5 months. The overall study duration is expected to be approximately 18 months.
Detailed description
High blood pressure (hypertension) is the leading risk factor for death globally. It affects approximately 30% of adults in the United Kingdom. Obesity is also serious, ongoing epidemic. Hypertension and obesity share a well-known association, but despite extensive research, the mechanisms underlying their association are still poorly understood. Approximately 50% of all hypertensive cases are linked to obesity, with an even greater proportion in young adults. Since one of the most common causes of high blood pressure is overweight or obesity, a healthy diet and weight loss are recommended for patients with stage 1 hypertension (clinic blood pressure ranging from 140/90 mmHg to 159/99 mmHg) before initiating blood pressure-lowering medications. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not maintained in the majority of cases. Therefore, further weight loss interventions could play a crucial role in the treatment of obesity and obesity-related hypertension.
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones with a variety of physiological actions. Their metabolic effects in the pancreas, stimulating glucose-dependent insulin secretion have led to the development of medications acting on these GLP-1 and GIP receptors for the treatment of type 2 diabetes mellitus, which are now well established. These new medications cause significant weight loss in adults with obesity and/or diabetes and are well tolerated. Beyond the substantial weight loss caused by these drugs, blood pressure also decreased significantly according to recent large studies. The blood pressure-lowering effect of these drugs may significantly contribute to the improved cardiovascular outcomes observed in previous large trials and analyses. Accordingly, these drugs could play a very important role in the treatment of hypertensive individuals with obesity. Whilst much of the blood pressure reduction elicited by these drugs could be mediated by the weight loss (~70% in recent trials), it is also possible based on previous experiments performed in animal models as well as human subjects that these drugs exert direct effects on the cardiovascular system.
The current study will examine the direct cardiovascular effects of the GLP-1 analogue semaglutide and the dual GIP/GLP-1 receptor agonist tirzepatide using two approaches: (i) investigation of the function of blood vessels in response to locally-acting infusions of semaglutide and tirzepatide into the forearm artery, and (ii) investigation of systemic effects [blood pressure, heart rate, cardiac output (amount of blood pumped by the heart per minute), vascular resistance] of semaglutide and tirzepatide in response to systemically-acting intravenous infusions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1A | Experimental | Drug: semaglutideIntra-arterial infusion of semaglutide |
| Sub-study 1B | Experimental | Drug: TirzepatideIntra-arterial infusion of Tirzepatide |
| Sub-study 1C | Experimental | Drug: semaglutide, Drug: TirzepatideIntra-arterial infusion of Saline, Semaglutide and Tirzepatide |
| Sub-study 2A | Experimental | Drug: semaglutideSlow intravenous bolus of Semaglutide |
| Sub-study 2B | Experimental | Drug: TirzepatideSlow intravenous bolus of Tirzepatide |
| Sub-study 2C | Experimental | Drug: semaglutide, Drug: TirzepatideSlow intravenous bolus of Semaglutide and Tirzepatide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Inclusion Criteria - Participants with normal weight and normal blood pressure
- Inclusion Criteria - Obese participants with normal blood pressure
- Inclusion Criteria - Obese participants with high blood pressure
Key exclusion criteria (23 listed)
- Regular use of medications with vasoactive or cardiac effects in normotensive individuals; inability or unwillingness to omit anti-hypertensive medications on the morning of the study visits in hypertensive individuals
- Hypersensitivity to any of the study drugs or excipients
- Known clinically significant valvular heart disease
- Implanted pacemaker 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 |
|---|---|---|
| semaglutideSemaglutide: GLP-1 analogue | Drug | Sub-study 1A, Sub-study 1C, Sub-study 2A, Sub-study 2C |
| TirzepatideTirzepatide: dual GIP/GLP-1 receptor agonist | Drug | Sub-study 1B, Sub-study 1C, Sub-study 2B, Sub-study 2C |
Primary outcome
Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Ratio)
Time frame: 2-2.5 months from screening to follow-up
Ratio, expressed as a number (no units as this is a ratio)
Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Absolute flow)
Time frame: 2-2.5 months from screening to follow-up
Absolute flow in the infused arm, in mL/min/100 mL
Sub-study 1A: Change in forearm blood flow parameters after infusion of semaglutide (Percentage Change)
Time frame: 2-2.5 months from screening to follow-up
Percentage change in the infused arm, in %
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Absolute flow)
Time frame: 2-2.5 months from screening to follow-up
Absolute flow in the infused arm, in mL/min/100 mL
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Ratio)
Time frame: 2-2.5 months from screening to follow-up
Ratio, expressed as a number (no units as this is a ratio)
Sub-study 1B: Change in forearm blood flow parameters after infusion of tirzepatide (Percent Change)
Time frame: 2-2.5 months from screening to follow-up
Percentage change in the infused arm, in %
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Absolute flow)
Time frame: 2-2.5 months from screening to follow-up
Absolute flow in the infused arm, in mL/min/100 mL
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Ratio)
Time frame: 2-2.5 months from screening to follow-up
Ratio, expressed as a number (no units as this is a ratio)
Sub-study 1C: Change in forearm blood flow parameters after infusion of semaglutide or tirzepatide or saline (Percentage change)
Time frame: 2-2.5 months from screening to follow-up
Percentage change in the infused arm, in %
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Blood pressure)
Time frame: 2-2.5 months from screening to follow-up
Blood pressure measured in mmHg
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Heart rate)
Time frame: 2-2.5 months from screening to follow-up
Heart rate measured in beats per minute (bpm)
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Cardiac output)
Time frame: 2-2.5 months from screening to follow-up
Cardiac output measured in L/min
Sub-study 2A: Changes in cardiovascular haemodynamic variables after administration of semaglutide (Vascular resistance)
Time frame: 2-2.5 months from screening to follow-up
Vascular resistance measured in dynes⋅sec⋅cm5
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Blood pressure)
Time frame: 2-2.5 months from screening to follow-up
Blood pressure measured in mmHg
Sub-study 2B: Changes in cardiovascular haemodynamic variables ) after administration of tirzepatide (Heart rate)
Time frame: 2-2.5 months from screening to follow-up
Heart rate measured in beats per minute (bpm)
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Cardiac output)
Time frame: 2-2.5 months from screening to follow-up
Cardiac output measured in L/min
Sub-study 2B: Changes in cardiovascular haemodynamic variables after administration of tirzepatide (Vascular resistance)
Time frame: 2-2.5 months from screening to follow-up
Vascular resistance measured in dynes⋅sec⋅cm5
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Blood pressure)
Time frame: 2-2.5 months from screening to follow-up
Blood pressure measured in mmHg
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Heart rate)
Time frame: 2-2.5 months from screening to follow-up
Heart rate measured in beats per minute (bpm)
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Cardiac output)
Time frame: 2-2.5 months from screening to follow-up
Cardiac output measured in L/min
Sub-study 2C: Changes in cardiovascular haemodynamic variables after administration of semaglutide or tirzepatide or saline (Vascular resistance)
Time frame: 2-2.5 months from screening to follow-up
Vascular resistance measured in dynes⋅sec⋅cm5
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 19 Mar 2026.
- Individual participant dataSharing planned: Undecided. Access to IPD may be granted if a prospective applicant submits a request. The request will be reviewed by the sponsor and the Chief Investigator, and access will be approved only where there are clear academic reasons to allow use of the data. An IPD sharing plan will be discussed and relevant data sharing agreements will be developed when required.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing semaglutide and Tirzepatide in people with Cardiovascular Diseases, 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 23 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: opening soon, as of the sponsor's last update on 19 Mar 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Guneswary Thaygaraja, Msc Genomic Medicine (01223 349762, cuh.cambs.cardiovascular@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-study 1A:Change in forearm blood flow parameters after infusion of semaglutide (Ratio) (time frame: 2-2.5 months from screening to follow-up). The study lists 21 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 19 Mar 2026.