Subcutaneous continuous infusion of G3215
Research type
Research Study
Full title
A randomised, placebo controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a continuous subcutaneous infusion of G3215 in adult subjects
IRAS ID
278196
Contact name
Stephen Bloom
Contact email
Sponsor organisation
Imperial College London
Eudract number
2020-000051-12
ISRCTN Number
ISRCTN67889041
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
Research Summary:
G3215, the study drug, is being developed as a potential treatment for obesity. A Phase I clinical trial was completed for G3215 between Jan 2015 to February 2019 (EudraCT Number
2014-003672-23) which confirmed its safety and tolerability. In particular, in Part C of this trial, G3215 was given to volunteers using a pump which slowly injected the medication under the skin via a soft plastic tube. These volunteers ate less and began to lose weight, with nausea (feeling sick) being the main side effect.In this clinical trial we will test G3215, when given using the pump for up to 14 days to male volunteers who are overweight or obese. We will randomly assign participants to receive either placebo (ordinary salt water solution) or the G3215, and volunteers will not be told what they are getting. We will recruit 3 groups comprising 8 volunteers per group, in which 6 will receive G3215 and 2 subjects will receive placebo. Up to 3 additional groups (up to 24 subjects) may be enrolled.
After screening by the study team and checks are made to ensure that the volunteers are eligible, the participants will be admitted to the Imperial Clinical Research Facility at Hammersmith Hospital. We will test their body's ability to process sugar during a glucose tolerance test and participants' appetite using a food study. We will start participants on an small dose of G3215 and gradually increase the dose over 4 days, checking to make sure that they do not experience side effects. They will be allowed to go home after 4 days, returning on days 7, 11, 13 to change over the pump syringes. We will repeat the glucose tolerance test and food intake study on day 13. The pump will be stopped and taken off on day 15.
Summary of Results:
This research investigated whether a combination drug based on two gut hormones is safe and well tolerated in adults with overweight or obesity. The drug (G3215) is able to activate the hormone receptors of two hormones called glucagon-like peptide (GLP-1) and glucagon. The research team completed a a phase 1 trial of the drug G3215 in overweight or obese participants, with or without type 2 diabetes. In this study twenty-three participants completed a 14-day continuous infusion of G3215 or placebo. We found that G3215 was safe and well tolerated. It also led to an average body weight loss of 2.39 kg compared with 0.84 kg with the placebo infusion. G3215 also led to a reduction in food consumption and improved lipid profile. In summary, we found that a 14 day infusion of G3215 is safe, well tolerated and offered weight loss benefits. These results support ongoing development of G3215 for the treatment of obesity and metabolic disease.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0411
Date of REC Opinion
9 Jun 2020
REC opinion
Further Information Favourable Opinion