Testing the safety and effects of a new study drug (GCG-06) in adult subjects (GCG-06 - first doses in human)
Obesity is a common health issue that can increase the risk of serious illnesses like heart disease, type 2 diabetes, and stroke. Researchers at Imperial College London are testing an experimental medicine called GCG-06 to see if it can safely help people manage their weight. GCG-06 works similarly to glucagon, a natural hormone that reduces appetite and helps the body burn energy. Because this is a 'first-in-human' study, the main goal is not weight loss yet, but making sure the drug is safe, finding out how the body processes it, and checking for side effects. The study is looking for healthy adults aged 18 to 70 who are a normal weight or slightly overweight. Participants will receive injections of either GCG-06 or a dummy treatment (placebo) and will stay on a research ward so doctors can monitor them closely.
At a glance
What is this study about?
Obesity affects millions of people across the UK. Carrying excess weight can put extra strain on the body and raise the chance of developing long-term conditions like type 2 diabetes, high blood pressure, and heart disease. While lifestyle changes are important, researchers are constantly searching for new, safe medicines that can support people in eating less and managing their weight.
This trial is testing a new experimental medicine called GCG-06. The drug works like glucagon, a hormone your body produces naturally. Glucagon plays an important role in metabolism: it helps control blood sugar, lowers appetite, and helps the body burn fuel. Scientists hope that GCG-06, potentially combined with other treatments in the future, could become an effective tool to help people lose weight.
Because GCG-06 has never been tested in humans before, this is a Phase I trial. The main focus is participant safety. Doctors will start with very small doses and monitor volunteers continuously to see how the medicine travels through the blood, how the body breaks it down, and what side effects it might cause.
Key takeaways
- This is a Phase I trial testing the experimental obesity drug GCG-06 in humans for the first time.
- The main goal is to check safety and side effects, not to provide personal weight loss.
- The study is for healthy adults aged 18 to 70 with a BMI between 20 and 30.
- Participation involves overnight stays on a hospital ward and several outpatient visits in London.
- Volunteers will be closely monitored by medical staff throughout the study.
Who may be eligible?
This trial is open to healthy men and women aged between 18 and 70. Participants must have a body mass index (BMI) between 20 and 30, meaning they are within a normal weight or slightly overweight range. Volunteers must be non-smokers and cannot be able to have children (for example, post-menopausal women or those who are surgically sterile), and must agree to study rules around contraception and health checks.
You cannot take part if you have diabetes, pre-diabetes, or a history of drug or alcohol misuse. People who drink more than 14 units of alcohol a week, or who have severe allergic conditions like bad asthma, severe eczema, or frequent migraines, are also excluded.
Additionally, you cannot join if you have a personal or family history of specific thyroid or pancreatic conditions, or if you have recently taken prescription medicines, over-the-counter remedies, or herbal supplements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged between 18 and 70.
- My BMI is between 20 and 30 (normal weight or slightly overweight).
- I am in good general health and do not have diabetes or pre-diabetes.
- I do not smoke and drink no more than 14 units of alcohol per week.
- I am not currently taking prescription medicines or regular supplements.
- I am able to stay overnight at the research clinic for several days.
What does participation involve?
Taking part involves joining one of two study groups: Part A or Part B. In both parts, you will receive the study medicine (or a harmless dummy injection called a placebo) as an injection just under the skin.
Part A tests a single dose and lasts up to 3 weeks. You would stay on the hospital ward for 4 nights in a row, followed by up to 3 clinic visits. Part B tests multiple doses over 5 weeks and lasts about 10 weeks in total. This part involves one 4-night clinic stay, up to four 2-night stays, and up to 6 outpatient visits.
During your clinic stays, doctors and nurses will monitor you closely. They will check your heart with ECG traces, take blood and urine samples, and test your blood sugar and energy levels. The trial team will also contact your GP before you join to ensure it is safe for you to take part.
Potential risks and benefits
Locations (1)
- HMRApproximateLondon, England
Common questions
What does 'first-in-human' mean?
It means the medicine has been tested thoroughly in laboratory studies, but this trial is the very first time it is being given to people. Doses start very low to protect your safety.
Will this trial help me lose weight?
No. Because this is an early safety study using low or single doses, you should not expect to lose weight by taking part.
What is a placebo?
A placebo looks identical to the real medicine but contains no active ingredients. It helps researchers compare the real drug against an inactive substance to see true effects and side effects.
Can I leave the study early if I want to?
Yes. Taking part is completely voluntary. You can change your mind and stop at any time, though the doctors will ask to do a final health check to make sure you are well.
Will my GP know I am taking part?
Yes. The trial team must contact your GP to confirm your medical history and make sure it is safe for you to take part before you can join.
How to find out more
Tricia Tan
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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