Study of the Gut Hormone Analogue G3215 in Adult Subjects | NCT02692040 | Trialant
NCT02692040
Sponsor
Imperial College London
Status
Completed
Last Update Posted
Dec 23, 2020Actual
Enrollment
90Actual
Phase
Phase 1
Conditions
Diabetes Mellitus
Obesity
Interventions
G3215
Placebo
Countries
United Kingdom
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT02692040
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2014/G3215/01
Secondary IDs
Not provided
Brief Title
Study of the Gut Hormone Analogue G3215 in Adult Subjects
Official Title
A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Gut Hormone Analogue G3215 in Adult Subjects
Acronym
Not provided
Organization
Imperial College LondonOTHER
Status Module
Record Verification Date
Nov 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 2015
Primary Completion Date
Jan 2019Actual
Completion Date
Jan 2019Actual
First Submitted Date
Jan 18, 2016
First Submission Date that Met QC Criteria
Feb 22, 2016
First Posted Date
Feb 25, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 11, 2020
Results First Submitted that Met QC Criteria
Nov 25, 2020
Results First Posted Date
Dec 23, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 25, 2020
Last Update Posted Date
Dec 23, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Imperial College LondonOTHER
Collaborators
Name
Class
Medical Research Council
OTHER_GOV
Covance
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Diabetes Mellitus
Obesity
Keywords
obesity
diabetes mellitus
glucagon-like peptide-1
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
90Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
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.
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.
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.
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]).
Drug: G3215
Drug: Placebo
Placebo (B) - saline
Placebo Comparator
5 subcutaneous injections of 0.9% saline, over a 4 week treatment period
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
G3215
Drug
Gut hormone analogue
0.1 mg dose G3215 (A1)
0.5 mg dose G3215 (A1)
1.5 mg dose G3215 (A1)
10 mg dose G3215 (A6)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
up to 28 days after dosing
Secondary Outcomes
Measure
Description
Time Frame
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
up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
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.
Accepts Healthy Volunteers
Yes
Sex
Male
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
60 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Jim Bush, PhD MRCS
Covance Clinical Research Unit
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Covance Clinical Research Unit
Leeds
LS2 9LH
United Kingdom
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Recruited by Covance Clinical Research Unit, Leeds, UK
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (A) - Saline
0.9% saline single subcutaneous injection
Placebo: 0.9% saline
FG001
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.
FG002
4 mg Dose G3215 (A2) With Varied Formulation
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG003
4 mg Dose G3215 (A3) With Varied Formulation
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG004
4 mg Dose G3215 (A4) With Varied Formulation
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG005
4 mg Dose G3215 (A5) With Varied Formulation
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG006
8 mg Dose G3215 (A7)
8 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG007
10 mg Dose G3215 (A6)
10 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG008
12 mg Dose G3215 (A8)
12 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG009
16 mg Dose G3215 (A9)
16 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG010
32 mg Dose G3215 (A10)
32 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG011
48 mg Dose G3215 (A11)
48 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
FG012
Placebo (B) - Saline
0.9% saline multiple subcutaneous injection:
5 injections over a 4 week treatment period
Placebo: 0.9% saline
FG013
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
FG014
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
FG015
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
FG016
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
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00010 subjects
FG0014 subjects
FG0025 subjects
FG0035 subjects
FG0044 subjects
FG0055 subjects
FG0065 subjects
FG0075 subjects
FG0085 subjects
FG0094 subjects
FG0105 subjects
FG0115 subjects
FG0126 subjects
FG0136 subjects
FG0146 subjects
FG0156 subjects
FG0164 subjects
COMPLETED
FG00010 subjects
FG0014 subjects
FG0025 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
A total of 90 male subjects entered the study and were randomised to treatment across Part A Single-dose (62 participants), Part B Multiple Ascending-dose (24 participants), and Part C (4 participants). In cohort 1 of Part A (SAD A1), 4 subjects received study drug (G3215 or saline) in 3 treatment periods; all other subjects in part A (A2-A11) received only a single dose.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (A2-A11) - Saline
Single subcutaneous injection of 0.9% saline
BG001
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.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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
Posted
Count of Participants
Participants
up to 28 days after dosing
ID
Title
Description
OG000
Placebo (A) - Saline
0.9% saline single subcutaneous injection
Placebo: 0.9% saline
OG001
0.1 mg Dose G3215 (A1)
0.1 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG002
Adverse Events Module
Frequency Threshold
0
Time Frame
Up to 21 weeks from participant start date
Description
The safety evaluation will include blood pressure, pulse rate, ECG parameters, clinical laboratory tests (haematology, serum biochemistry, coagulation, urinalysis and urine microscopy).
5 doses over a 4 week treatment period at escalating doses to a max of 24 mg.
G3215: Gut hormone analogue
BG014
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
BG015
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
BG016
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
BG017
Total
Total of all reporting groups
10
BG0014
BG0025
BG0035
BG0044
BG0055
BG0065
BG0075
BG0085
BG0094
BG0105
BG0115
BG0126
BG0136
BG0146
BG0156
BG0164
BG01790
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00040.1± 16.2
BG00147± 14.0
BG00239± 7.3
BG00340± 8.8
BG00438± 10.1
BG00547± 14.3
BG00630± 15.2
BG00748± 7.9
BG00833± 12.8
BG00945± 9.0
BG01039± 11.7
BG01149± 10.9
BG01247± 8.7
BG01345± 4.3
BG01447± 13.7
BG01545± 14.0
BG01648± 16.3
BG01742.7± 12.2
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Male
BG00010
BG0014
BG0025
BG0035
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
Not Hispanic or Latino
BG00010
BG0014
BG0025
BG0035
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United Kingdom
Title
Measurements
BG00010
BG0014
BG0025
BG0035
BG0044
BG0055
BG0065
BG0075
BG0085
BG0094
BG0105
BG0115
BG0126
BG0136
BG0146
BG0156
BG0164
BG01798
Body Weight (kg)
Mean
Standard Deviation
kg
Title
Denominators
Categories
Title
Measurements
BG00088.9± 10.20
BG00189.2± 7.75
BG00283.7± 7.98
BG00399.6± 10.72
BG00494.6± 7.00
BG00592.2± 9.34
BG00692.3± 8.46
BG00792.1± 9.48
BG00892.4± 8.32
BG00996.3± 16.36
BG01089.3± 5.16
BG01185.9± 14.88
BG01288.3± 10.42
BG01390.2± 3.08
BG01492.1± 13.72
BG01593.6± 13.51
BG01687.9± 5.68
BG01790.9± 9.9
BMI (kg/m^2)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00028.5± 2.51
BG00129.1± 1.80
BG00227.4± 1.94
BG00329.8± 2.97
BG00428.5± 2.46
BG00529.5± 2.24
BG00630.0± 2.98
BG00729.3± 3.45
BG00828.2± 2.50
BG00929.7± 4.31
BG01028.8± 1.78
BG01128.0± 3.38
BG01228.6± 3.72
BG01329.0± 1.76
BG01429.4± 3.94
BG01529.5± 3.40
BG01629.0± 1.48
BG01728.9± 2.7
0.5 mg Dose G3215 (A1)
0.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG003
1.5 mg Dose G3215 (A1)
1.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG004
4 mg Dose G3215 (A2)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG005
4 mg Dose G3215 (A3)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG006
4 mg Dose G3215 (A4)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG007
4 mg Dose G3215 (A5)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG008
8 mg Dose G3215 (A7)
8 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG009
10 mg Dose G3215 (A6)
10 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG010
12 mg Dose G3215 (A8)
12 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG011
16 mg Dose G3215 (A9)
16 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG012
32 mg Dose G3215 (A10)
32 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG013
48 mg Dose G3215 (A11)
48 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG014
Placebo (B) - Saline
0.9% saline multiple subcutaneous injection: 5 injections over a 4 week treatment period
Placebo: 0.9% saline
OG015
5mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses
G3215: Gut hormone analogue
OG016
6 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses
G3215: Gut hormone analogue
OG017
7 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG018
8 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG019
10 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG020
12 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG021
16 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG022
20 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG023
24 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
OG024
Placebo (C)
Placebo: 0.9% saline
OG025
0.6 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 0.6 mg over 24h treatment period.
G3215: Gut hormone analogue
OG026
0.7 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 0.7 mg over 24h treatment period.
G3215: Gut hormone analogue
OG027
0.8 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 0.8 mg over 24h treatment period.
G3215: Gut hormone analogue
OG028
1 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 1 mg over 24h treatment period.
G3215: Gut hormone analogue
OG029
1.1 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 1.1 mg over 24h treatment period.
G3215: Gut hormone analogue
OG030
1.4 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 1.4 mg over 24h treatment period.
G3215: Gut hormone analogue
OG031
1.5 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 1.5 mg over 24h treatment period.
G3215: Gut hormone analogue
OG032
1.8 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 1.8 mg over 24h treatment period.
G3215: Gut hormone analogue
OG033
2.2 mg/24h (C) Infusion Pump Dose of G3215
G3215 subcutaneous infusion of 2.2 mg over 24h treatment period.
G3215: Gut hormone analogue
Units
Counts
Participants
OG00013
OG0013
OG0023
OG0033
OG0045
OG0055
OG0064
OG0075
OG0085
OG0095
OG0105
OG0114
OG0125
OG0135
OG0146
OG0156
OG0166
OG0176
OG0186
OG0198
OG0201
OG0217
OG0223
OG0236
OG0244
OG0251
OG0262
OG0271
OG0281
OG0291
OG0301
OG0313
OG0321
OG0331
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
OG0033
OG0044
OG0054
OG0062
OG0074
OG0084
OG0095
OG0105
OG0114
OG0125
OG0135
OG0142
OG0155
OG0166
OG0175
OG0186
OG0197
OG0200
OG0214
OG0223
OG0236
OG0241
OG0251
OG0262
OG0270
OG0281
OG0291
OG0301
OG0312
OG0321
OG0331
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
Completers
Posted
Mean
Standard Deviation
Percentage change
up to day 4 (am) for Part A, day 31 (pm) for Part B and day 5 (am) for Part C
ID
Title
Description
OG000
Placebo (A) - Saline
0.9% saline
Placebo: 0.9% saline
OG001
0.1 mg Dose G3215 (A1)
0.1 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG002
0.5 mg Dose G3215 (A1)
0.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG003
1.5 mg Dose G3215 (A1)
1.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG004
4 mg Dose G3215 (A2)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG005
4 mg Dose G3215 (A3)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG006
4 mg Dose G3215 (A4)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG007
4 mg Dose G3215 (A5)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG008
8 mg Dose G3215 (A7)
8 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG009
10 mg Dose G3215 (A6)
10 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG010
12 mg Dose G3215 (A8)
12 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG011
16 mg Dose G3215 (A9)
16 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG012
32 mg Dose G3215 (A10)
32 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG013
48 mg Dose G3215 (A11)
48 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
OG014
Placebo (B) - Saline
0.9% saline
Placebo: 0.9% saline
OG015
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
OG016
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
OG017
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
OG018
Infusion Pump Dose of G3215 (C)
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
OG019
Placebo (Part C)
Placebo infusion received on day 4 of infusion pump study
Units
Counts
Participants
OG00013
OG0013
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.1± 0.97
OG0010.2± 0.47
OG0020.8± 0.15
OG003
0
13
0
13
5
13
EG001
0.1 mg Dose G3215 (A1)
0.1 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
3
0
3
1
3
EG002
0.5 mg Dose G3215 (A1)
0.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
3
0
3
3
3
EG003
1.5 mg Dose G3215 (A1)
1.5 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
3
0
3
3
3
EG004
4 mg Dose G3215 (A2)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
5
5
EG005
4 mg Dose G3215 (A3)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
4
5
EG006
4 mg Dose G3215 (A4)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
1
4
1
4
4
4
EG007
4 mg Dose G3215 (A5)
4 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
4
5
EG008
8 mg Dose G3215 (A7)
8 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
4
5
EG009
10 mg Dose G3215 (A6)
10 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
5
5
EG010
12 mg Dose G3215 (A8)
12 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
5
5
EG011
16 mg Dose G3215 (A9)
16 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
4
0
4
4
4
EG012
32 mg Dose G3215 (A10)
32 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
5
5
EG013
48 mg Dose G3215 (A11)
48 mg G3215 single dose, subcutaneous injection
G3215: Gut hormone analogue
0
5
0
5
5
5
EG014
Placebo (B) - Saline
0.9% saline, multiple subcutaneous injections 5 injections over a 4 week treatment period
Placebo: 0.9% saline
0
6
0
6
5
6
EG015
5 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
6
0
6
5
6
EG016
6 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
6
0
6
6
6
EG017
7 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
6
0
6
6
6
EG018
8 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
6
0
6
6
6
EG019
10 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
8
0
8
7
8
EG020
12 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
1
0
1
0
1
EG021
16 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
0
7
0
7
5
7
EG022
20 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
3
3
0
3
3
3
EG023
24 mg G3215 (B)
G3215 multiple dose, subcutaneous injection:
5 doses over a 4 week treatment period at escalating doses.
G3215: Gut hormone analogue
6
6
0
6
6
6
EG024
Placebo (C)
Placebo: 0.9% saline subcutaneous infusion over a 24 hour treatment period
4
4
0
4
1
4
EG025
0.6 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 0.6 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
1
1
EG026
0.7 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 0.7 mg over a 24 hour treatment period
G3215: Gut hormone analogue
2
2
0
2
2
2
EG027
0.8 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 0.8 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
0
1
EG028
1 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 1 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
1
1
EG029
1.1 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 1.1 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
1
1
EG030
1.4 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 1.4 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
1
1
EG031
1.5 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 1.5 mg over a 24 hour treatment period
G3215: Gut hormone analogue
3
3
0
3
2
3
EG032
1.8 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 1.8 mg over a 24 hour treatment period
G3215: Gut hormone analogue
1
1
0
1
1
1
EG033
2.2 mg/24h (C) Infusion Rate Pump of G3215
G3215 subcutaneous infusion of 2.2 mg over a 24 hour treatment period