Obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Subjects will be randomised to GLP-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 parts
Sponsors
Imperial College London
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male non-smokers aged 18-70 years; body mass index 23 - 45 kg/m² 2. Healthy volunteers (Part A) 3. For part B only: either healthy volunteers, or those diagnosed with prediabetes or impaired glucose tolerance or impaired fasting glucose or type 2 diabetes but otherwise in good health, as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests; able to communicate with study personnel 4. Reliable, willing, and likely to comply with the protocol; willing to comply with the contraception and sperm donation requirements of the protocol.
Exclusion criteria
Exclusion criteria: 1. Not healthy (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine); 2. Abuse or have abused alcohol or drugs in the last 2 years; 3. Have been treated by a doctor for severe allergic disease (such as severe asthma, or severe hayfever requiring regular treatment) 4. Currently taking certain medicines to treat diabetes; 5. Taken prescription medicine during the 14 days before dosing; For Part B participants who are stably treated for their diabetes with certain therapy are allowed; 6. Taken other medicine (except paracetamol or vitamins), herbal remedies or dietary supplements during the 7 days before first dose; 7. Have clinically relevant surgical history; 8. Have had a serious reaction to any medicine; 9. Have had pancreatitis or pancreatic cancer, 10. Have acute gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea, heartburn) at screening or admission 11. Have had any condition or operation that might affect the way the body absorbs medicines; 12. Have had any clinically significant disease; 13. Taken GLP-06 in the past 14. Are vegans, or have any significant non-religious dietary restriction which will impact the trial; 15. Mental illness might compromise consent; 16. Have history or have abnormal eating behaviour as observed through the Dutch Eating Behaviour (DEBQ) and SCOFF questionnaires at screening; 17. Unwilling to comply with the contraception requirements of the protocol — because of the potential risk to babies conceived during the study; 18. Have donated plasma in the 7 days before screening, or 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); 19. Objection by GP on medical grounds — because they might increase the risk, or confound the assessment of GLP-06; 20. Have had or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 21. Have had an episode of hypoglycaemia 22. Who have a history of diabetic retinopathy These criteria are designed to select healthy participants, who are robust enough to recover quickly from any adverse effects of GLP-06. We'll study overweight and obese participants because they are the target population for the study medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
|---|---|
| To evaluate the pharmacokinetic parameters (plasma) of single and multiple doses of GLP-06: 1.1. Part A: In each TP, blood samples will be collected often during Day 1, on Days 2, 3, 4, and at each OP and at FU. 1.2. Part B: In each TP, blood samples will be collected often during dosing days, on Day 30, on OP visits, and at FU visit. | — |
Countries
England, United Kingdom
Outcome results
None listed