This 56-week Phase 2 clinical trial is evaluating an investigational treatment consisting of oral tablets taken twice daily together with a once-weekly self-administered injection. The study is designed to assess whether this investigational medicine, in combination with semaglutide compared with semaglutide alone, may help improve total body fat reduction and overall body composition.
If eligible, you will take part in the study for up to 56 weeks, including a 24-week treatment phase followed by a 24-week maintenance phase for eligible participants, and a short follow-up period. Clinic visits occur approximately once per month, with additional visits during screening and follow-up.
All study visits will take place during clinic business hours 9am-5pm weekdays, and because fasting blood tests are required, most appointments will be scheduled in the morning.
Participants are randomly assigned to one of four groups, with a 25% chance of being placed in each group, and neither you nor the study team will know which combination you receive.
Throughout the study, your health will be monitored through physical examinations, vital signs, ECGs, fasting blood tests, weight and waist measurements, and lifestyle counselling. All participants will undergo DEXA and MRI scans to assess body composition, and some participants may also be invited to complete additional optional procedures.
Before enrolling, the study doctor will explain all study requirements, potential risks, and what participation involves. Eligible participants will receive $2600 reimbursement for study-related time and travel.