Obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Subjects will be randomised to GCG-06 or placebo, administered by subcutaneous (SC) injection.
Allocation to treatment will be according to a predetermined random order.
The trial will be in 2 par
Sponsors
Zihipp Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and females of non-childbearing potential non-smokers aged 18-70 years old 2. Body mass index 20-30 kg/m2 3. In good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests 4. Able to communicate with study personnel 5. Reliable, willing, and likely to comply with the protocol 6. Willing to comply with the contraception and gamete donation requirements of the protocol and consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS).
Exclusion criteria
Exclusion criteria: 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 prediabetes 3. Abuse or have abused alcohol or drugs in the last 2 years 4. Drink, on average, more than 14 units of alcohol weekly 5. 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 diabetes 7. 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 medicine 8. Have suffered from migraines in the last 3 years 9. Have a clinically relevant surgical history 10. Have had a serious reaction to any medicine 11. History of pancreatitis or pancreatic cancer 12. A history or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 13. 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 medicines 15. Have had any clinically significant disease 16. Taken GCG-06 in the past 17. Have a history or evidence of abnormal eating behaviour 18. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study 19. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability will be assessed by the following measures: 1. Incidence and severity of adverse events (AEs) monitored continuously throughout the study 2. Changes in vital signs (blood pressure, pulse rate, temperature), 12-lead ECGs, physical examination, bedside glucose monitoring and local tolerability assessment to be monitored over the study period 3. Changes in clinical laboratory safety results monitored over the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters (plasma) of GCG-06. *Part A: Blood samples for assay of GCG-06 will be taken before dosing and frequently up to 12 h after dosing, on Days 2, 3, 4, and at each outpatient visit on Days 7 & 14 and at the final follow-up visit. *Part B: In each TP, blood samples will be collected often during dosing days, on Day 30, on OP visits, and at the follow-up visit. | — |
Countries
England, United Kingdom
Outcome results
None listed