Study Information:
This clinical research study is evaluating an investigational long-acting amylin analogue treatment (administered as a once-weekly, every other week or a once a month self-administered injection) for weight management. The investigational treatment is a man-made protein that works like a naturally occurring hormone in your body. This hormone tells your brain you feel full after eating. Researchers are investigating whether different dose levels of this investigational treatment may support weight management in adults living with obesity, or who are overweight and have a weight-related health condition, when combined with diet and physical activity guidance.
Who is it for?
You may be eligible if you:
- Are aged 18 to 75 years
- Have obesity (BMI ≥30)
-
OR
Are overweight (BMI ≥27) and have a weight‑related health condition such as:
- High blood pressure
- High cholesterol
- Prediabetes
- Obstructive sleep apnoea
- Fatty liver disease (also known as non‑alcoholic fatty liver disease, MASLD/MASH)
- Have previously tried to lose weight through dietary measures
- Have not had a significant change in body weight (greater than 5%) in the past 3 months
- Have not been diagnosed with diabetes
- Are not currently using prescription weight‑loss medications
- Are willing and able to attend scheduled study visits and complete study assessments
What does study participation look like?
If eligible, participation includes a screening period, a treatment period, and a follow‑up period.
Participants will be randomly assigned to receive investigational treatment or placebo. Neither participants nor the study team will know which treatment has been assigned during the study.
The study treatment is self‑administered as an injection under the skin (subcutaneous injection).
Participation includes approximately 52 weeks of treatment, followed by a 60‑day follow‑up period, with around 17 clinic visits. Researchers will closely monitor participants’ health, wellbeing, and safety throughout the study.
Study procedures may include physical examinations, blood tests, fasting assessments, body measurements, questionnaires, medical history reviews, and other health assessments.
Clinic visits will take place during business hours of 9:00 am–5:00 pm, weekdays. The length of each visit may vary depending on the assessments required at that stage of the study.