GCG-06 – first doses in humans
Research type
Research Study
Full title
A randomised, placebo-controlled first in human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GCG-06 in healthy normal weight/overweight subjects
IRAS ID
1006692
Contact name
Sadia Abdullah
Contact email
Sponsor organisation
Imperial College London
Eudract number
2022-003579-40
ISRCTN Number
ISRCTN69500549
Research summary
This is a study of GCG-06 (the study medicine), an experimental new medicine for treating obesity. Obesity is a common problem and can lead to some serious and potentially life-threatening conditions, such as heart disease, type 2 diabetes and stroke. GCG-06 is similar to a natural occurring hormone in the body called glucagon, which increases the level of sugar in the blood. We hope that the GCG-06 can be used together with other hormone-related medicines to help people eat less and reduce their body weight.
This is a 2-part study (Parts A and B) in normal weight and overweight men, aged 18–70. We’ll test single and repeated doses of GCG-06, given by injection under the skin. We aim to find out its side effects and blood levels, and its effect on body weight, and how the body handles glucose (a type of sugar) and amino acid (building blocks that make up protein).
In Part A we’ll test single doses of GCG-06 or placebo, in up to 8 groups (42 participants in total). GCG-06 has never been given to humans before, so we’ll start with a small dose, and increase it as the study progresses. Participants will have 1 study session and take up to about 3 weeks to finish the study. They’ll stay on the ward for 4 nights in a row and make up to 3 outpatient visits.
In Part B we’ll test repeated doses of GCG-06 or placebo (3 or 5 doses over 5 weeks), in up to 4 groups (32 participants in total). Participants will take about 10 weeks to finish the study. They’ll stay on the ward for up to 4 nights in a row on 1 occasion and up to 2 nights in a row on up to 4 occasions, and make up to 8 outpatient visits.
Imperial College London is funding and is the sponsor of the study.
The study will take place at 1 centre in London.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0226
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion