Research Study Evaluating an Investigational Weight-Loss Medication

About the Study

This study is evaluating a new investigational medication that may help support weight loss and improve metabolic health in adults living with obesity or who are overweight.

The investigational medicine is given as a once-weekly injection and is designed to work with the body’s natural pathways involved in appetite regulation and energy balance. By supporting these processes, the medicine may help promote sustained weight loss.

This study aims to evaluate the safety and effectiveness of an investigational medication when used over an extended period in adults who do not have diabetes.

Who is it for?

• You are 18 years or older
• You have a BMI of 35 kg/m² or higher
• You do not have diabetes
• You have tried to lose weight with diet and exercise without long-term success
• You are willing to attend regular morning, fasted clinic visits
• You are willing to self-administer a once-weekly injection
• You are using reliable contraception (if applicable)
• You are able to commit to the full study duration (up to 84 weeks)

What to Expect During Study Participation

If eligible, you will take part in the study for up to 84 weeks, including screening, treatment, and a safety follow-up period. The study involves 15 clinic visits and 7 phone calls, with clinic visits occurring approximately every four weeks. Most clinic visits require fasting and will take place during clinic business hours Monday to Friday 9am to 5pm.

During the study, you will receive a once-weekly subcutaneous (under the skin) injection of either the investigational medicine, an approved weight-loss medication, or a placebo. Participants are randomly assigned to treatment groups. Some treatments in this study are blinded, meaning that you may not know which treatment you are receiving.

Throughout the study, doctors and nurses will closely monitor your health, body weight, and overall wellbeing through regular check-ups and testing.

Study assessments may include medical history collection, physical examinations, vital signs, ECGs, blood tests, BMI and waist circumference measurements, sit-to-stand functional assessments, pregnancy testing and contraceptive counselling (if applicable), lifestyle support guidance, nutritional counselling, and investigational product administration.

Before enrolling, the study doctor and clinical team will explain the study in detail, including findings from previous research, potential risks and benefits, and what participation involves.

Eligible participants will receive up to $4420 reimbursement for study-related time and travel.