Diabetes MellitusPhase 1NCT03673111

Study of the Gut Hormone Analogue Y14 in Adult Subjects

A Phase 1 study testing Y14 in people with Diabetes Mellitus and Obesity, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Obesity
What is being tested?: Y14
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 77 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Apr 2017to 13 Feb 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 38.0 kg/m2 inclusive;
(PART B only) Subjects who have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria;
Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12-lead ECG;
Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator;
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;
Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions;

Show all 10Show fewer

Subjects who are non-smokers for at least 3 months preceding screening;
Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration;
Subjects who agree not to donate sperm for at least 3 months after study drug administration;
Subjects who are able and willing to give written informed consent.

Who cannot join

Subjects who do not conform to the above inclusion criteria;
Subjects who have a clinically relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;
Subjects who have a clinically relevant surgical history;
Subjects who are currently taking any of the following classes of diabetes medications: thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), GLP-1 analogues, and insulin;
Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week);
Subjects who have a history of relevant drug hypersensitivity;

Show all 24Show fewer

Subjects who have a history of alcohol abuse or alcohol dependence according to DSMIV criteria within the last 2 years;
Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years;
Subjects who have a history of clinically significant migraine as judged by the Investigator. Subjects can be included if they have not had a migraine for the last 3 years;
Subjects with a history of pancreatitis or pancreatic cancer;
Subjects who consume more than 21 units of alcohol a week (unit = 1 glass of wine (125 mL) = 1 measure of spirits = ½ pint of beer);
Subjects who have a significant infection or known inflammatory process on screening;
Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn);
Subjects who have an acute infection such as influenza at the time of screening or admission;
Subjects who have used prescription drugs within 2 weeks of first dosing. For Part B, patients are allowed to be treated for their diabetes with monotherapy with a sulphonylurea, metformin, or a SGLT-2 inhibitor, dual therapy with any two of the following drug types: a sulphonylurea, metformin, and/or a SGLT-2 inhibitor; triple therapy with a sulphonylurea, metformin, and a SGLT-2 inhibitor. In addition patients in Part B are allowed to take hypolipidaemic and/or antihypertensive treatments, provided that the doses have not been altered within the 4 weeks prior to entering the study. Other medications may be allowed if the Investigator and Sponsor both agree that they will not affect the outcome of the study or the safety of the subject.
Subjects who have used over the counter medication excluding routine vitamins and paracetamol but including megadose (intake of 20 to 600 times the recommended daily dose) vitamin therapy within 7 days of first dosing, unless agreed as not clinically relevant by the Principal Investigator and Sponsor;
Subjects who have donated blood within 3 months prior to screening; Subjects who have donated plasma within the 7 days prior to screening; Subjects who have donated platelets within the 6 weeks prior to screening
Subjects who have used any investigational drug in any clinical trial within 3 months of their first admission date;
Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up;
Subjects who have previously received Y14;
Subjects who are vegans, vegetarian or have any dietary restriction (unless agreed as not clinically relevant by the PI and Sponsors);
Subjects who cannot communicate reliably with the Investigator;
Subjects who are unlikely to co-operate with the requirements of the study;
History or evidence of abnormal eating behaviour, as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Covance Clinical Research Unit
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Randomised, Placebo Controlled First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y14 in Adult Subjects

A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.

Read the detailed description

Objectives:

Primary Objective

To investigate the safety and tolerability of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To investigate the safety and tolerability of multiple doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Secondary Objectives

To assess the pharmacokinetic (PK) profile of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To assess the PK profile of multiple ascending doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Exploratory Objective

To investigate the effects of multiple doses of Y14 on food consumption, body weight and glucose tolerance in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Conditions: Diabetes Mellitus, Obesity
Being tested: Y14, Placebo
Medical subject headings: Diabetes Mellitus, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Y14Drug
Also called Gut hormone analogue
Gut hormone analogue
PlaceboDrug
Also called Saline
0.9% saline

Study groups in NCT03673111
Study group	Role	What they receive
1.0 mg Y14 (A1)	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
2.0 mg Y14 (A1)	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
6.0 mg Y14 (A1)	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
9.0 mg Y14 (A2) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
18.0 mg Y14 (A5) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
36.0 mg Y14 (A6) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
Placebo (B)	Placebo comparator	5 subcutaneous injections of 0.9% saline, over a 4 week treatment period Receives: Drug: Placebo
9-26.0 mg (B1)	Experimental	Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses to a max of 26 mg Receives: Drug: Y14
9-36 mg (B2)	Experimental	Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg Receives: Drug: Y14
12-36 mg (B3)	Experimental	Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg Receives: Drug: Y14
Placebo (A)	Placebo comparator	Single subcutaneous injection of 0.9% saline Receives: Drug: Placebo
9 mg Y14 (A3) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
9 mg Y14 (A4) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
18 mg Y14 (A7) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
36 mg Y14 (A8) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14
36 mg Y14 (A9) with varied formulation	Experimental	Y14 single dose, subcutaneous Receives: Drug: Y14

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)
As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters.
Possibly or definitely related to study drug
Measured: Up to 73 days after dosing

Secondary outcomes (4)

Cmax
The maximum observed concentration
Measured: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
AUC 0-72h
The area under the concentration versus time curve from time zero to 72 h postdose, calculated by the mixed linear/log trapezoidal rule
Measured: Up to 72hr after dosing
AUC 0-τ
The area under the concentration versus time curve within a (168 h) dosing interval, calculated by the mixed linear/log trapezoidal rule (equivalent to AUC0-168h, which was calculated as the area under the concentration versus time curve from time zero to 168 h post-dose after a single dose, calculated by the mixed linear/log trapezoidal rule).
Measured: Up to 168h after dosing
T 1/2
Drug Half-life (t1/2) is defined as the amount of time (hours) required for the drug concentration to be reduced to exactly half its initial concentration or amount in blood.
The apparent terminal half-life, calculated from Loge 2 / λz:
For Part A cohorts, it was not possible to estimate an unambiguous Tmax or T1/2 due to the extended PK profile of Y14.
For Part B cohorts, no individual administered dose half-life data were collected for this outcome, but one half-life value was measured after all doses had been administered and these values were analysed only for the treated-arms that is B1, B2 and B3.
Measured: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201713 Feb 2019

First posted17 Sep 2018
Study start10 Apr 2017
Primary completion13 Feb 2019
Study completion13 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03673111
Sponsor's protocol ID: ICIM/2016/Y14/01
Other IDs: 2017-000380-33, 2017
Status last verified: Mar 2025
First submitted: 23 May 2018
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tan TM, Minnion J, Khoo B, Ball LJ, Malviya R, Day E, Fiorentino F, Brindley C, Bush J, Bloom SR. Safety and efficacy of an extended-release peptide YY analogue for obesity: A randomized, placebo-controlled, phase 1 trial. Diabetes Obes Metab. 2021 Jul;23(7):1471-1483. doi: 10.1111/dom.14358. Epub 2021 Mar 9.
PubMed 33606914

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Placebo Controlled First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y14 in Adult Subjects
ClinicalTrials.gov ID: NCT03673111
Acronym / sponsor ID: ICIM/2016/Y14/01
Conditions: Diabetes Mellitus, Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: Medical Research Council, Covance
Study start: 10 Apr 2017 (actual)
Primary completion: 13 Feb 2019 (actual)
Study completion: 13 Feb 2019 (actual)
First posted: 17 Sep 2018 (actual)
Results: Posted 18 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.

Detailed description

Objectives:

Primary Objective

To investigate the safety and tolerability of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To investigate the safety and tolerability of multiple doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Secondary Objectives

To assess the pharmacokinetic (PK) profile of single doses of Y14 in overweight/obese but otherwise healthy male subjects.
To assess the PK profile of multiple ascending doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Exploratory Objective

To investigate the effects of multiple doses of Y14 on food consumption, body weight and glucose tolerance in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, care provider)
Number of arms: 16

Arm	Type	Receives
1.0 mg Y14 (A1)	Experimental	Drug: Y14Y14 single dose, subcutaneous
2.0 mg Y14 (A1)	Experimental	Drug: Y14Y14 single dose, subcutaneous
6.0 mg Y14 (A1)	Experimental	Drug: Y14Y14 single dose, subcutaneous
9.0 mg Y14 (A2) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
18.0 mg Y14 (A5) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
36.0 mg Y14 (A6) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
Placebo (B)	Placebo comparator	Drug: Placebo5 subcutaneous injections of 0.9% saline, over a 4 week treatment period
9-26.0 mg (B1)	Experimental	Drug: Y14Y14 multiple dose, subcutaneous 5 doses over a 4 week treatment period: escalating doses to a max of 26 mg
9-36 mg (B2)	Experimental	Drug: Y14Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg
12-36 mg (B3)	Experimental	Drug: Y14Y14 multiple dose, subcutaneous 4 doses over a 4 week treatment period: escalating doses to a max of 36 mg
Placebo (A)	Placebo comparator	Drug: PlaceboSingle subcutaneous injection of 0.9% saline
9 mg Y14 (A3) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
9 mg Y14 (A4) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
18 mg Y14 (A7) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
36 mg Y14 (A8) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous
36 mg Y14 (A9) with varied formulation	Experimental	Drug: Y14Y14 single dose, subcutaneous

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Adult males aged 18 to 65 years inclusive with BMI between 25.0 and 38.0 kg/m2 inclusive;
(PART B only) Subjects who have normal glucose tolerance, Type 2 diabetes, impaired glucose tolerance or impaired fasting glucose according to WHO 2006 and 2011 criteria;
Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12-lead ECG;
Subjects whose clinical laboratory test results are either within the normal range or if outside this range the abnormalities are judged to be not clinically relevant and are acceptable to the Investigator;
Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening;

Key exclusion criteria (24 listed)

Subjects who do not conform to the above inclusion criteria;
Subjects who have a clinically relevant history or presence of gastrointestinal (especially associated with vomiting), respiratory, renal, hepatic, haematological, lymphatic, neurological (especially if associated with balance disorders or vomiting e.g. migraine or labyrinthitis), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders;
Subjects who have a clinically relevant surgical history;
Subjects who are currently taking any of the following classes of diabetes medications: thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), GLP-1 analogues, and insulin;
Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week), severe eczema requiring regular treatment (i.e. taking antihistamines and/or glucocorticoids more regularly than 3 times a week);

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
Y14Also: Gut hormone analogueGut hormone analogue	Drug	1.0 mg Y14 (A1), 12-36 mg (B3), 18 mg Y14 (A7) with varied formulation, 18.0 mg Y14 (A5) with varied formulation, 2.0 mg Y14 (A1), 36 mg Y14 (A8) with varied formulation, 36 mg Y14 (A9) with varied formulation, 36.0 mg Y14 (A6) with varied formulation, 6.0 mg Y14 (A1), 9 mg Y14 (A3) with varied formulation, 9 mg Y14 (A4) with varied formulation, 9-26.0 mg (B1), 9-36 mg (B2), 9.0 mg Y14 (A2) with varied formulation
PlaceboAlso: Saline0.9% saline	Drug	Placebo (A), Placebo (B)

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)
Time frame: Up to 73 days after dosing
As assessed by reporting of adverse events, vital signs, physical examination, clinical laboratory safety assessments, and ECG parameters. Possibly or definitely related to study drug

4 secondary outcomes

Cmax
Time frame: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose
AUC 0-72h
Time frame: Up to 72hr after dosing
AUC 0-τ
Time frame: Up to 168h after dosing
T 1/2
Time frame: For Part A, Cohorts A3 to A9 - up to 840 hour post dose. For Part B - up to day 70 post 1st dose

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Y14 Single Ascending Dose (A1: TP1, TP2 & TP3)	5	4
9.0 mg (A2)	5	5
9 mg (A3)	5	5
9 mg (A4)	5	5
18.0 mg (A5)	5	5
36.0 mg (A6)	5	5
18 mg (A7)	5	5
36 mg (A8)	5	5
36 mg (A9)	5	5
Placebo SAD (A2-A9)	8	8
Placebo (Part B)	6	5
9-26.0 mg (B1)	6	6
9-36 mg (B2)	6	6
12-36 mg (B3)	6	6

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability)

Time frame: Up to 73 days after dosing. Count of participants. Unit: Participants

Measure	Placebo (A1) n = 3	1.0 mg (A1) TP1 n = 3	2.0 mg (A1) TP2 n = 3	6.0 mg (A1) TP3 n = 3	9 mg (A4) n = 5	9 mg (A3) n = 5	9.0 mg (A2) n = 5	18 mg (A7) n = 5	18.0 mg (A5) n = 5	36 mg (A8) n = 5	36.0 mg (A6) n = 5	36 mg (A9) n = 5	Placebo SAD A2-A9 n = 8	Placebo (Part B) n = 6	9 mg Y14 (B1) n = 6	9 mg Y14 (B2) n = 6	12 mg Y14 (B1) n = 6	12 mg Y14 (B3) n = 6	16 mg Y14 (B1) n = 6	20 mg Y14 (B1) n = 6	24 mg Y14 (B2) n = 6	24 mg Y14 (B3) n = 6	26 mg Y14 (B1) n = 6	36 mg Y14 (B2) n = 6	36 mg Y14 (B3) n = 6
Value	2	1	1	3	5	4	1	5	5	4	5	5	3	3	5	4	6	5	6	6	6	5	6	5	6

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 21 weeks from participant start date. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (A1)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
1.0 mg (A1) TP1	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
2.0 mg (A1) TP2	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
6.0 mg (A1) TP3	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Placebo SAD (A2-A9)	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
9 mg (A4)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
9 mg (A3)	0 of 5 (0%)	4 of 5 (80%)	0 of 5
9.0 mg (A2)	0 of 5 (0%)	1 of 5 (20%)	0 of 5
18 mg (A7)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
18.0 mg (A5)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
36 mg (A8)	0 of 5 (0%)	4 of 5 (80%)	0 of 5
36.0 mg (A6)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
36 mg (A9)	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Placebo (Part B)	0 of 6 (0%)	3 of 6 (50%)	0 of 6
9 mg Y14 (B1)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
9 mg Y14 (B2)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
12 mg Y14 (B1)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
12 mg Y14 (B3)	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
16 mg Y14 (B1)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
20 mg Y14 (B1)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
24 mg Y14 (B2)	0 of 6 (0%)	6 of 6 (100%)	0 of 6
24 mg Y14 (B3)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33606914Tan TM, Minnion J, Khoo B, Ball LJ, Malviya R, Day E, Fiorentino F, Brindley C, Bush J, Bloom SR. Safety and efficacy of an extended-release peptide YY analogue for obesity: A randomized, placebo-controlled, phase 1 trial. Diabetes Obes Metab. 2021 Jul;23(7):1471-1483. doi: 10.1111/dom.14358. Epub 2021 Mar 9.
Individual participant dataSharing planned: No

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Stephen Bloom, FMedSci, FRS study director

Sponsor Chief Investigator, Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Y14 in people with Diabetes Mellitus and Obesity, run by Imperial College London 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 10 inclusion and 24 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: finished, as of the sponsor's last update on 18 Mar 2025. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (Safety and Tolerability) (time frame: Up to 73 days after dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673111, which also lists 1 linked publication.

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 18 Mar 2025.