G3215 Single and multiple ascending dose study
Research type
Research Study
Full title
A randomised, placebo controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects.
IRAS ID
164403
Contact name
Steve Bloom
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
0 years, 9 months, 14 days
Research summary
G3125, the study drug being developed as a potential treatment for Obesity.
This is a first time in man study conducted in two parts.
This Study uses a placebo control, some participants will receive the active Study Drug and some will receive placebo as an injection under the skin. Which participants receive Drug or placebo will be determined randomly.
In Part A approximately 28 healthy overweight, male volunteers will be studied in 5 groups. Group 1 will involve 4 participants (3 active and 1 placebo); each dosed in three treatment periods (TP) with three ascending dose levels , with minimum 1 week between each TP. Groups 2 to 5 will comprise 6 volunteers (5 active and 1 placebo) each. Each volunteer in group 2-5 will participate in one TP only.
In Part B participants will be overweight male volunteers who have been diagnosed with Type 2 diabetes (mild) or prediabetes. The intention is to investigate 3 dose levels in up to 3 groups, each of 8 volunteers (6 active and 2 placebo). An additional group (up to 16 volunteers) may be enrolled depending on safety results of the previous groups. Volunteers will receive 5 doses of G3215/placebo each separated by 7 days.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1239
Date of REC Opinion
10 Dec 2014
REC opinion
Further Information Favourable Opinion