Diabetes MellitusPhase 1NCT02692040
Study of the Gut Hormone Analogue G3215 in Adult Subjects
A Phase 1 study testing G3215 in people with Diabetes Mellitus and Obesity, run by Imperial College London at 1 site in United Kingdom.
Trial summary
A randomised, placebo controlled Phase I study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Obesity
- What is being tested?
- G3215
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jan 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult males aged 18 to 60 years inclusive with body mass index (BMI) between 25.0 and 35.0 kg/m2 inclusive;
- 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;
- 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 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 thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter (SGLT-2) inhibitors, and insulin;
- Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment, severe eczema requiring regular treatment;
- 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 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria within the last two 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; monotherapy with sulphonylureas, or metformin. 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 G3215;
- Subjects who are vegans or have any dietary restrictions;
- 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 (Sick, Control, One Stone, Fat, Food) questionnaires at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Gut Hormone Analogue G3215 in Adult Subjects
A randomised, placebo controlled Phase I study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects.
Read the detailed description
Objectives:
Primary Objective
- To investigate the safety and tolerability of single doses of G3215 in overweight but otherwise healthy male subjects.
- To investigate the safety and tolerability of multiple doses of G3215 in overweight male subjects with mild stable Type 2 diabetes or prediabetes.
Secondary Objectives • To assess the pharmacokinetic (PK) profile of single and multiple ascending doses of G3215 in overweight but otherwise healthy male subjects or overweight / obese male subjects with mild stable Type 2 diabetes or prediabetes.
Exploratory Objective
- To investigate the effects of multiple doses of G3215 on food consumption, body weight, enteropancreatic hormone changes and glucose tolerance in overweight male subjects with mild Type 2 diabetes or prediabetes.
- Conditions
- Diabetes Mellitus, Obesity
- Being tested
- G3215, Placebo
- Keywords
- obesity, diabetes mellitus, glucagon-like peptide-1
- 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.
G3215Drug
Gut hormone analogue
PlaceboDrug
Also called Saline
0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| 12-24 mg (B1) dose of G3215 | Experimental | G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 24 mg. Receives: Drug: G3215 |
| 6-10 mg (B2) dose of G3215 | Experimental | G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 10 mg. Receives: Drug: G3215 |
| 5-16 mg (B3) dose of G3215 | Experimental | G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 16 mg. Receives: Drug: G3215 |
| 3.2mg (C) infusion pump dose of G3215 | Experimental | G3215 subcutaneous infusion over a 4 day treatment period at escalating doses to a max of 3.2 mg (with either the first or last day administering infusion of placebo [saline]). Receives: Drug: G3215; Drug: Placebo |
| Placebo (B) - saline | Placebo comparator | 5 subcutaneous injections of 0.9% saline, over a 4 week treatment period Receives: Drug: Placebo |
| Placebo (A) - saline | Placebo comparator | Single subcutaneous injection of 0.9% saline Receives: Drug: Placebo |
| 0.1 mg dose G3215 (A1) | Experimental | 0.1 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 0.5 mg dose G3215 (A1) | Experimental | 0.5 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 1.5 mg dose G3215 (A1) | Experimental | 1.5 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 4 mg dose G3215 (A2) with varied formulation | Experimental | 4 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 4 mg dose G3215 (A3) with varied formulation | Experimental | 4 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 4 mg dose G3215 (A4) with varied formulation | Experimental | 4 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 4 mg dose G3215 (A5) with varied formulation | Experimental | 4 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 8 mg dose G3215 (A7) | Experimental | 8 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 10 mg dose G3215 (A6) | Experimental | 10 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 12 mg dose G3215 (A8) | Experimental | 12 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 16 mg dose G3215 (A9) | Experimental | 16 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 32 mg dose G3215 (A10) | Experimental | 32 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
| 48 mg dose G3215 (A11) | Experimental | 48 mg G3215 single dose, subcutaneous injection Receives: Drug: G3215 |
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 28 days after dosing
Secondary outcomes (1)
Body Weight (Percentage Change From Baseline)
Summary of Time-Matched % Change from Baseline in Body Weight (AM Baseline = Day 1 AM; PM Baseline = Day -1 PM
Measured: up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2019
- Study completionJan 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.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, Covance
- Responsible party
- Sponsor
- Investigators
- Jim Bush, PhD MRCS, Principal investigator, Covance Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692040
- Sponsor's protocol ID
- 2014/G3215/01
- Status last verified
- Nov 2020
- First submitted
- 18 Jan 2016
- Last updated
- 23 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Gut Hormone Analogue G3215 in Adult Subjects
- ClinicalTrials.gov ID
- NCT02692040
- Acronym / sponsor ID
- 2014/G3215/01
- Conditions
- Diabetes Mellitus, Obesity
- Keywords
- obesity, diabetes mellitus, glucagon-like peptide-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, Covance
- Study start
- Jan 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 23 Dec 2020
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 the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects.
Detailed description
Objectives:
Primary Objective
- To investigate the safety and tolerability of single doses of G3215 in overweight but otherwise healthy male subjects.
- To investigate the safety and tolerability of multiple doses of G3215 in overweight male subjects with mild stable Type 2 diabetes or prediabetes.
Secondary Objectives • To assess the pharmacokinetic (PK) profile of single and multiple ascending doses of G3215 in overweight but otherwise healthy male subjects or overweight / obese male subjects with mild stable Type 2 diabetes or prediabetes.
Exploratory Objective
- To investigate the effects of multiple doses of G3215 on food consumption, body weight, enteropancreatic hormone changes and glucose tolerance in overweight male subjects with mild Type 2 diabetes or prediabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| 12-24 mg (B1) dose of G3215 | Experimental | Drug: G3215G3215 multiple dose, subcutaneous injection: 5 doses over a 4 week treatment period at escalating doses to a max of 24 mg. |
| 6-10 mg (B2) dose of G3215 | Experimental | Drug: G3215G3215 multiple dose, subcutaneous injection: 5 doses over a 4 week treatment period at escalating doses to a max of 10 mg. |
| 5-16 mg (B3) dose of G3215 | Experimental | Drug: G3215G3215 multiple dose, subcutaneous injection: 5 doses over a 4 week treatment period at escalating doses to a max of 16 mg. |
| 3.2mg (C) infusion pump dose of G3215 | Experimental | Drug: G3215, Drug: PlaceboG3215 subcutaneous infusion over a 4 day treatment period at escalating doses to a max of 3.2 mg (with either the first or last day administering infusion of placebo [saline]). |
| Placebo (B) - saline | Placebo comparator | Drug: Placebo5 subcutaneous injections of 0.9% saline, over a 4 week treatment period |
| Placebo (A) - saline | Placebo comparator | Drug: PlaceboSingle subcutaneous injection of 0.9% saline |
| 0.1 mg dose G3215 (A1) | Experimental | Drug: G32150.1 mg G3215 single dose, subcutaneous injection |
| 0.5 mg dose G3215 (A1) | Experimental | Drug: G32150.5 mg G3215 single dose, subcutaneous injection |
| 1.5 mg dose G3215 (A1) | Experimental | Drug: G32151.5 mg G3215 single dose, subcutaneous injection |
| 4 mg dose G3215 (A2) with varied formulation | Experimental | Drug: G32154 mg G3215 single dose, subcutaneous injection |
| 4 mg dose G3215 (A3) with varied formulation | Experimental | Drug: G32154 mg G3215 single dose, subcutaneous injection |
| 4 mg dose G3215 (A4) with varied formulation | Experimental | Drug: G32154 mg G3215 single dose, subcutaneous injection |
| 4 mg dose G3215 (A5) with varied formulation | Experimental | Drug: G32154 mg G3215 single dose, subcutaneous injection |
| 8 mg dose G3215 (A7) | Experimental | Drug: G32158 mg G3215 single dose, subcutaneous injection |
| 10 mg dose G3215 (A6) | Experimental | Drug: G321510 mg G3215 single dose, subcutaneous injection |
| 12 mg dose G3215 (A8) | Experimental | Drug: G321512 mg G3215 single dose, subcutaneous injection |
| 16 mg dose G3215 (A9) | Experimental | Drug: G321516 mg G3215 single dose, subcutaneous injection |
| 32 mg dose G3215 (A10) | Experimental | Drug: G321532 mg G3215 single dose, subcutaneous injection |
| 48 mg dose G3215 (A11) | Experimental | Drug: G321548 mg G3215 single dose, subcutaneous injection |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Adult males aged 18 to 60 years inclusive with body mass index (BMI) between 25.0 and 35.0 kg/m2 inclusive;
- 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;
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 thiazolidinediones, dipeptidyl peptidase IV inhibitors ('gliptins'), glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose co-transporter (SGLT-2) inhibitors, and insulin;
- Subjects who have a history of relevant and severe atopy e.g. asthma, angioedema requiring emergency treatment, severe hayfever requiring regular treatment, severe eczema requiring regular treatment;
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 |
|---|---|---|
| G3215Gut hormone analogue | Drug | 0.1 mg dose G3215 (A1), 0.5 mg dose G3215 (A1), 1.5 mg dose G3215 (A1), 10 mg dose G3215 (A6), 12 mg dose G3215 (A8), 12-24 mg (B1) dose of G3215, 16 mg dose G3215 (A9), 3.2mg (C) infusion pump dose of G3215, 32 mg dose G3215 (A10), 4 mg dose G3215 (A2) with varied formulation, 4 mg dose G3215 (A3) with varied formulation, 4 mg dose G3215 (A4) with varied formulation, 4 mg dose G3215 (A5) with varied formulation, 48 mg dose G3215 (A11), 5-16 mg (B3) dose of G3215, 6-10 mg (B2) dose of G3215, 8 mg dose G3215 (A7) |
| PlaceboAlso: Saline0.9% saline | Drug | 3.2mg (C) infusion pump dose of G3215, Placebo (A) - saline, Placebo (B) - saline |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]
Time frame: up to 28 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
1 secondary outcome
Body Weight (Percentage Change From Baseline)
Time frame: up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jim Bush, PhD MRCS principal investigator
Covance Clinical Research Unit
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 G3215 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 8 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 23 Dec 2020. 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 23 Dec 2020). 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 28 days after dosing). 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 23 Dec 2020.