Diabetes Mellitus, Obesity
Conditions
Keywords
obesity, diabetes mellitus, glucagon-like peptide-1
Brief summary
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.
Interventions
DRUGPlacebo
0.9% saline
DRUGG3215
Gut hormone analogue
Sponsors
Medical Research Council
Covance
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult males aged 18 to 60 years inclusive with body mass index (BMI) between 25.0 and 35.0 kg/m2 inclusive; 2. Subjects who are otherwise healthy enough to participate, as determined by pre-study medical history, physical examination and 12 lead ECG; 3. 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; 4. Subjects who are negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening; 5. Subjects who are negative for drugs of abuse and alcohol tests at screening and admissions; 6. Subjects who are non-smokers for at least 3 months preceding screening; 7. Subjects who agree to use medically acceptable methods of contraception for at least 3 months after study drug administration; 8. Subjects who are able and willing to give written informed consent.
Exclusion criteria
1. Subjects who do not conform to the above inclusion criteria; 2. 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; 3. Subjects who have a clinically relevant surgical history; 4. 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; 5. 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; 6. Subjects who have a history of relevant drug hypersensitivity; 7. 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; 8. Subjects who have a history of drug or substance abuse according to DSM-IV criteria within the last 2 years; 9. 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; 10. Subjects with a history of pancreatitis or pancreatic cancer; 11. 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); 12. Subjects who have a significant infection or known inflammatory process on screening; 13. Subjects who have acute gastrointestinal symptoms at the time of screening or admission (e.g. nausea, vomiting, diarrhoea, heartburn); 14. Subjects who have an acute infection such as influenza at the time of screening or admission; 15. 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. 16. 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; 17. 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 18. Subjects who have used any investigational drug in any clinical trial within 3 months of their first admission date; 19. Subjects who have received the last dose of investigational drug greater than 3 months ago but who are on extended follow-up; 20. Subjects who have previously received G3215; 21. Subjects who are vegans or have any dietary restrictions; 22. Subjects who cannot communicate reliably with the Investigator; 23. Subjects who are unlikely to co-operate with the requirements of the study; 24. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight (Percentage Change From Baseline) | up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C | Summary of Time-Matched % Change from Baseline in Body Weight (AM Baseline = Day 1 AM; PM Baseline = Day -1 PM |
Countries
United Kingdom
Participant flow
Recruitment details
Recruited by Covance Clinical Research Unit, Leeds, UK
Participants by arm
| Arm | Count |
|---|---|
| Placebo (A2-A11) - Saline Single subcutaneous injection of 0.9% saline | 10 |
| G3215 Single Ascending Dose (A1) Sequential cross-over group received either Saline or 0.1 mg dose G3215 (A1) single dose, subcutaneous injection in the first treatment period; Saline or 0.5 mg dose G3215 single dose, subcutaneous injection in the second period, Saline or 1.5 mg dose G3215 single dose, subcutaneous injection in the third treatment period. Treatment periods were 12-15 days apart. | 4 |
| 4 mg Dose G3215 (A2) 4 mg G3215 single dose, subcutaneous injection | 5 |
| 4 mg Dose G3215 (A3) 4 mg G3215 single dose, subcutaneous injection | 5 |
| 4 mg Dose G3215 (A4) 4 mg G3215 single dose, subcutaneous injection | 4 |
| 4 mg Dose G3215 (A5) 4 mg G3215 single dose, subcutaneous injection | 5 |
| 8 mg Dose G3215 (A7) 8 mg G3215 single dose, subcutaneous injection | 5 |
| 10 mg Dose G3215 (A6) 10 mg G3215 single dose, subcutaneous injection | 5 |
| 12 mg Dose G3215 (A8) 12 mg G3215 single dose, subcutaneous injection | 5 |
| 16 mg Dose G3215 (A9) 16 mg G3215 single dose, subcutaneous injection | 4 |
| 32 mg Dose G3215 (A10) 32 mg G3215 single dose, subcutaneous injection | 5 |
| 48 mg Dose G3215 (A11) 48 mg G3215 single dose, subcutaneous injection | 5 |
| Placebo (B) - Saline 0.9% saline multiple subcutaneous injection
5 injections over a 4 week treatment period
Placebo: 0.9% saline | 6 |
| 12-24 mg (B1) Dose of G3215 G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 24 mg.
G3215: Gut hormone analogue | 6 |
| 6-10 mg (B2) Dose of G3215 G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 10 mg.
G3215: Gut hormone analogue | 6 |
| 5-16 mg (B3) Dose of G3215 G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses to a max of 16 mg.
G3215: Gut hormone analogue | 6 |
| 3.2mg (C) Infusion Pump Dose of G3215 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 \[saline\]).
G3215: Gut hormone analogue
Placebo: 0.9% saline | 4 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 5-16 mg (B3) Dose of G3215 | 4 mg Dose G3215 (A3) | 12 mg Dose G3215 (A8) | 3.2mg (C) Infusion Pump Dose of G3215 | 4 mg Dose G3215 (A2) | G3215 Single Ascending Dose (A1) | 10 mg Dose G3215 (A6) | 32 mg Dose G3215 (A10) | Placebo (B) - Saline | 48 mg Dose G3215 (A11) | 12-24 mg (B1) Dose of G3215 | 8 mg Dose G3215 (A7) | 4 mg Dose G3215 (A5) | 16 mg Dose G3215 (A9) | Total | 6-10 mg (B2) Dose of G3215 | Placebo (A2-A11) - Saline | 4 mg Dose G3215 (A4) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 14 | 40 years STANDARD_DEVIATION 8.8 | 33 years STANDARD_DEVIATION 12.8 | 48 years STANDARD_DEVIATION 16.3 | 39 years STANDARD_DEVIATION 7.3 | 47 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 7.9 | 39 years STANDARD_DEVIATION 11.7 | 47 years STANDARD_DEVIATION 8.7 | 49 years STANDARD_DEVIATION 10.9 | 45 years STANDARD_DEVIATION 4.3 | 30 years STANDARD_DEVIATION 15.2 | 47 years STANDARD_DEVIATION 14.3 | 45 years STANDARD_DEVIATION 9 | 42.7 years STANDARD_DEVIATION 12.2 | 47 years STANDARD_DEVIATION 13.7 | 40.1 years STANDARD_DEVIATION 16.2 | 38 years STANDARD_DEVIATION 10.1 |
| BMI (kg/m^2) | 29.5 kg/m^2 STANDARD_DEVIATION 3.4 | 29.8 kg/m^2 STANDARD_DEVIATION 2.97 | 28.2 kg/m^2 STANDARD_DEVIATION 2.5 | 29.0 kg/m^2 STANDARD_DEVIATION 1.48 | 27.4 kg/m^2 STANDARD_DEVIATION 1.94 | 29.1 kg/m^2 STANDARD_DEVIATION 1.8 | 29.3 kg/m^2 STANDARD_DEVIATION 3.45 | 28.8 kg/m^2 STANDARD_DEVIATION 1.78 | 28.6 kg/m^2 STANDARD_DEVIATION 3.72 | 28.0 kg/m^2 STANDARD_DEVIATION 3.38 | 29.0 kg/m^2 STANDARD_DEVIATION 1.76 | 30.0 kg/m^2 STANDARD_DEVIATION 2.98 | 29.5 kg/m^2 STANDARD_DEVIATION 2.24 | 29.7 kg/m^2 STANDARD_DEVIATION 4.31 | 28.9 kg/m^2 STANDARD_DEVIATION 2.7 | 29.4 kg/m^2 STANDARD_DEVIATION 3.94 | 28.5 kg/m^2 STANDARD_DEVIATION 2.51 | 28.5 kg/m^2 STANDARD_DEVIATION 2.46 |
| Body Weight (kg) | 93.6 kg STANDARD_DEVIATION 13.51 | 99.6 kg STANDARD_DEVIATION 10.72 | 92.4 kg STANDARD_DEVIATION 8.32 | 87.9 kg STANDARD_DEVIATION 5.68 | 83.7 kg STANDARD_DEVIATION 7.98 | 89.2 kg STANDARD_DEVIATION 7.75 | 92.1 kg STANDARD_DEVIATION 9.48 | 89.3 kg STANDARD_DEVIATION 5.16 | 88.3 kg STANDARD_DEVIATION 10.42 | 85.9 kg STANDARD_DEVIATION 14.88 | 90.2 kg STANDARD_DEVIATION 3.08 | 92.3 kg STANDARD_DEVIATION 8.46 | 92.2 kg STANDARD_DEVIATION 9.34 | 96.3 kg STANDARD_DEVIATION 16.36 | 90.9 kg STANDARD_DEVIATION 9.9 | 92.1 kg STANDARD_DEVIATION 13.72 | 88.9 kg STANDARD_DEVIATION 10.2 | 94.6 kg STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 90 Participants | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 6 participants | 5 participants | 5 participants | 4 participants | 5 participants | 4 participants | 5 participants | 5 participants | 6 participants | 5 participants | 6 participants | 5 participants | 5 participants | 4 participants | 98 participants | 6 participants | 10 participants | 4 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 5 Participants | 6 Participants | 5 Participants | 5 Participants | 4 Participants | 90 Participants | 6 Participants | 10 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 5 | 0 / 5 | 1 / 4 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 1 | 0 / 7 | 3 / 3 | 6 / 6 | 4 / 4 | 1 / 1 | 2 / 2 | 1 / 1 | 1 / 1 | 1 / 1 | 1 / 1 | 3 / 3 | 1 / 1 | 1 / 1 |
| other Total, other adverse events | 5 / 13 | 1 / 3 | 3 / 3 | 3 / 3 | 5 / 5 | 4 / 5 | 4 / 4 | 4 / 5 | 4 / 5 | 5 / 5 | 5 / 5 | 4 / 4 | 5 / 5 | 5 / 5 | 5 / 6 | 5 / 6 | 6 / 6 | 6 / 6 | 6 / 6 | 7 / 8 | 0 / 1 | 5 / 7 | 3 / 3 | 6 / 6 | 1 / 4 | 1 / 1 | 2 / 2 | 0 / 1 | 1 / 1 | 1 / 1 | 1 / 1 | 2 / 3 | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 13 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 5 | 0 / 5 | 1 / 4 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 4 | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 1 | 0 / 7 | 0 / 3 | 0 / 6 | 0 / 4 | 0 / 1 | 0 / 2 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 1 | 0 / 3 | 0 / 1 | 0 / 1 |
Outcome results
Primary
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
Time frame: up to 28 days after dosing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (A) - Saline | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 2 Participants |
| 0.1 mg Dose G3215 (A1) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 0 Participants |
| 0.5 mg Dose G3215 (A1) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 0 Participants |
| 1.5 mg Dose G3215 (A1) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 3 Participants |
| 4 mg Dose G3215 (A2) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 4 mg Dose G3215 (A3) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 4 mg Dose G3215 (A4) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 2 Participants |
| 4 mg Dose G3215 (A5) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 8 mg Dose G3215 (A7) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 10 mg Dose G3215 (A6) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| 12 mg Dose G3215 (A8) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| 16 mg Dose G3215 (A9) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 32 mg Dose G3215 (A10) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| 48 mg Dose G3215 (A11) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| Placebo (B) - Saline | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 2 Participants |
| 5mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| 6 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 6 Participants |
| 7 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 5 Participants |
| 8 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 6 Participants |
| 10 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 7 Participants |
| 12 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 0 Participants |
| 16 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 4 Participants |
| 20 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 3 Participants |
| 24 mg G3215 (B) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 6 Participants |
| Placebo (C) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 0.6 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 0.7 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 2 Participants |
| 0.8 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 0 Participants |
| 1 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 1.1 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 1.4 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 1.5 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 2 Participants |
| 1.8 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
| 2.2 mg/24h (C) Infusion Pump Dose of G3215 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] | 1 Participants |
Secondary
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
Time frame: up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C
Population: Completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (A) - Saline | Body Weight (Percentage Change From Baseline) | 0.1 Percentage change | Standard Deviation 0.97 |
| 0.1 mg Dose G3215 (A1) | Body Weight (Percentage Change From Baseline) | 0.2 Percentage change | Standard Deviation 0.47 |
| 0.5 mg Dose G3215 (A1) | Body Weight (Percentage Change From Baseline) | 0.8 Percentage change | Standard Deviation 0.15 |
| 1.5 mg Dose G3215 (A1) | Body Weight (Percentage Change From Baseline) | 0.1 Percentage change | Standard Deviation 0.42 |
| 4 mg Dose G3215 (A2) | Body Weight (Percentage Change From Baseline) | 0.9 Percentage change | Standard Deviation 0.68 |
| 4 mg Dose G3215 (A3) | Body Weight (Percentage Change From Baseline) | 0.2 Percentage change | Standard Deviation 0.49 |
| 4 mg Dose G3215 (A4) | Body Weight (Percentage Change From Baseline) | -0.7 Percentage change | Standard Deviation 0.29 |
| 4 mg Dose G3215 (A5) | Body Weight (Percentage Change From Baseline) | 0.4 Percentage change | Standard Deviation 0.7 |
| 8 mg Dose G3215 (A7) | Body Weight (Percentage Change From Baseline) | -0.7 Percentage change | Standard Deviation 0.73 |
| 10 mg Dose G3215 (A6) | Body Weight (Percentage Change From Baseline) | -1.4 Percentage change | Standard Deviation 0.44 |
| 12 mg Dose G3215 (A8) | Body Weight (Percentage Change From Baseline) | -0.1 Percentage change | Standard Deviation 0.53 |
| 16 mg Dose G3215 (A9) | Body Weight (Percentage Change From Baseline) | -0.1 Percentage change | Standard Deviation 0.51 |
| 32 mg Dose G3215 (A10) | Body Weight (Percentage Change From Baseline) | -1.7 Percentage change | Standard Deviation 1.16 |
| 48 mg Dose G3215 (A11) | Body Weight (Percentage Change From Baseline) | -0.9 Percentage change | Standard Deviation 0.74 |
| Placebo (B) - Saline | Body Weight (Percentage Change From Baseline) | -1.4 Percentage change | Standard Deviation 1.26 |
| 5mg G3215 (B) | Body Weight (Percentage Change From Baseline) | -3.7 Percentage change | Standard Deviation 2.58 |
| 6 mg G3215 (B) | Body Weight (Percentage Change From Baseline) | -5.3 Percentage change | Standard Deviation 3.79 |
| 7 mg G3215 (B) | Body Weight (Percentage Change From Baseline) | -4.5 Percentage change | Standard Deviation 1.72 |
| 8 mg G3215 (B) | Body Weight (Percentage Change From Baseline) | -3.2 Percentage change | Standard Deviation 0 |
| 10 mg G3215 (B) | Body Weight (Percentage Change From Baseline) | -3.0 Percentage change | Standard Deviation 0 |