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Contact Information:

Prof Tricia Tan
+44 (0)20 7594 2665
t.tan@imperial.ac.uk


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Be Part of Research - Trial Details - Testing the safety and effects of a new study drug (GCG-06) in adult subjects (GCG-06 - first doses in human)
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Testing the safety and effects of a new study drug (GCG-06) in adult subjects (GCG-06 - first doses in human)

Recruiting

Open to: All Genders

Age: Mixed

London

Medical Conditions

Obesity

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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 naturally occurring hormone in the body called glucagon, which increases the level of sugar in the blood, reduces appetite, and increases how we burn fuel. It is hoped that the GCG-06 can be used together with other hormone-related medicines to help people eat less and reduce their body weight.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

02 Jan 2024 01 Oct 2024

This is a 2-part study (Parts A and B). The study will test single and repeated doses of GCG-06, given by injection under the skin. It aims to find out its side effects and blood levels, 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, single doses of GCG-06 or placebo will be tested in up to 8 groups (42 participants in total). GCG-06 has never been given to humans before, so the starting dose will be small, and it will be increased as the study progresses. Participants will have 1 study session and take up to 3 weeks to finish the study. They will stay on the ward for 4 nights in a row and attend up to 3 outpatient visits.

In Part B, repeated doses of GCG-06 or placebo will be tested as 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 will 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 attend up to 6 outpatient visits.


Normal weight and overweight subjects, aged 18–70 years old

You can take part if:



You may not be able to take part if:


1. Unhealthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine)2. Diabetes or prediabetes3. Abuse or have abused alcohol or drugs in the last 2 years4. Drink, on average, more than 14 units of alcohol weekly5. Have been treated by a doctor for severe allergic disease (such as severe asthma, severe hay fever requiring regular treatment, or severe eczema) 6. Currently taking certain medicines to treat diabetes7. Taken prescription medicine during the 14 days before dosing; taken other medicine (except paracetamol or routine vitamins), herbal remedies or dietary supplements during the 7 days before the first dose; have had a serious reaction to any medicine8. Have suffered from migraines in the last 3 years9. Have a clinically relevant surgical history10. Have had a serious reaction to any medicine11. History of pancreatitis or pancreatic cancer12. A history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 213. Have acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heartburn) at screening or admission 14. Have a current infection (such as flu)15. Have had any condition or operation that might affect the way the body absorbs medicines15. Have had any clinically significant disease16. Taken GCG-06 in the past 17. Have a history or evidence of abnormal eating behaviour18. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study19. Have donated plasma in the 7 days before screening, blood in the 3 months before screening, or platelets in the 6 weeks before screening; have taken part in another clinical trial within 3 months before the first admission or are in the follow-up period of a clinical trial (where the last dose was taken more than 3 months before); or don't agree to donate blood, or take part in another study, during the 3 months after this study — because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood;20. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of GCG-06; mental illness might compromise consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • HMR
    Cumberland Avenue
    London
    NW10 7EW

To date, no humans have taken GCG-06, so its side effects are unknown. The study medicine has been thoroughly tested in laboratory animals. The highest dose that can be tested in this study is one that is predicted will give blood levels of the study medicine that were safe in animals.
Other medicines similar to the study medicine have been given to many people. The most common side effects are feeling sick (nausea), being sick (vomiting) and abdominal pain. As nausea and vomiting are expected to be the most common side effects, anti-emetics (anti-sickness medicine) will be available at the clinical unit.
Another side effect is high blood sugar (hyperglycaemia), so the participant's blood sugar level will be measured often. Hyperglycaemia tends to settle with time, but on rare occasions, this may result in the body breaking down fat cells excessively instead of sugar to produce energy, which can lead to an increased level of a chemical called ketone in the body. If a participant has hyperglycaemia, the study team will closely monitor the level of ketones in their blood and provide the appropriate level of care. In this study, participants will be closely monitored, and the dose of GCG-06 will not be increased unless the previous dose causes no important side effects. If a participant withdraws, they are asked to consent to a final follow-up. Consent is documented using an information and consent form (ICF), which has been approved by the HRA’s Generic Review Committee (GRC; REC ref: 18/GR/0054).
Like other similar medicines, reactions can occur at or near the site of injection. Symptoms might include redness, tenderness, itching and discomfort. Rarely, the study medicine might cause an allergic reaction, and result in more serious symptoms such as breathing difficulty, rash or low blood pressure up to 24 h after the dose. Participants will be closely monitored, to make sure they have not had a reaction. If they do have a reaction, appropriate medicine will be provided, as needed.
A volunteer’s immune system might make antibodies against the study medicine. Those antibodies might stop the study medicine (or similar medicines) from working if they ever needed it in the future. In Part B, blood from participants in Group 1 will be tested to see if they make antibodies against the study medication.
During their stay, participants must follow HMR’s ‘house rules’. Our information leaflet is given to volunteers at screening and has been approved by the GRC (REC ref: 18/GR/0104).
If a participant’s partner becomes pregnant during the study, they will be asked to contact their GP about the pregnancy – which is documented using a generic ICF that has been approved by the HRA’s GRC (REC ref: 18/GR/0055 or 21/GR/16).
If any medically important problem is found at screening, the physician will tell the participant in person, and pass on the results to the participant’s GP, using a letter template, which has been approved by the GRC (REC ref: 18/GR/0101).
The study team will contact participants’ GPs to inform them that their patient has volunteered to participate in a study and provide the GP with a study summary. For first-in-human studies, the GP is asked if there is any medical problem that might compromise the volunteer’s safety during the study. The GP letter templates have been approved by the GRC (REC refs: 18/GR/0098 and 18/GR/0099). Participants consent to the study team contacting their GP when they sign the ICF.
Please refer to the ICF(s) for Part A (version 2, dated 14 Nov 2023), and Part B (version 2, dated 14 Nov 2023), submitted with this application, for details on procedural risks, lifestyle and fasting restrictions, COVID-19 vaccine restrictions, and contraception requirements.

Prof Tricia Tan
+44 (0)20 7594 2665
t.tan@imperial.ac.uk



The study is sponsored by Imperial College London and funded by Imperial College London.



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Read full details for Trial ID: ISRCTN69500549
Last updated 04 March 2024

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