GLP-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 GLP-06 in adult subjects
IRAS ID
1006364
Contact name
Benjamin Woods
Contact email
Sponsor organisation
Imperial College London
Eudract number
2022-003227-18
Research summary
This is a study of GLP-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. GLP-06 is similar to a natural occurring hormone in the body called glucagon like peptide 1 (GLP1). We hope GLP-06 will work by reducing appetite, so people feel fuller and less hungry. We hope this will help people eat less food and reduce their body weight. This is a 2-part study (Parts A and B) in men who are overweight or obese, aged 18–70. We’ll test single and repeated doses of GLP-06, given by slow injection under the skin. We aim to find out its side effects and blood levels, and its effect on food intake, body weight, and how the body handles glucose (a type of sugar).
In Part A we’ll test single doses of GLP-06 or placebo, in up to 6 groups (30 participants in total). The study medicine has never been given to humans before, so we’ll start with a small dose, and increase it as the study progresses. Participants in Part A 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 GLP-06 or placebo (up to 5 doses over 5 weeks), in up to 3 groups (24 participants in total). Participants will take up to 10 weeks to finish the study. They’ll stay on the ward for up to 5 nights in a row on 1 occasion and up to 2 nights in a row on up to 4 occasions, and make up to 6 outpatient visits.Imperial College London is funding the study.
The study will take place at 1 centre in London.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0459
Date of REC Opinion
9 Jun 2023
REC opinion
Further Information Favourable Opinion