Are you Struggling With Obesity, or Being Overweight?
The main purpose of this study is to evaluate the safety and efficacy of a once-weekly, experimental medication for participants who have obesity or are overweight, including subsets of participants who have knee osteoarthritis or who have obstructive sleep apnea. The study will last about 89 weeks and will include up to 24 visits.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others struggling with obesity, and whether it will be made widely available to all Canadians trying to manage obesity. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Have a body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
- hypertension
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease
- Have a history of of at least one unsuccessful dietary effort to reduce body weigh
- For the GOA1 Sub-study:
- Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month
- Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
- For the GSA1 Sub-study:
- Previously diagnosed with OSA
- Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OS)
- For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
- If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
You may not qualify to participate if you:
- Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment for obesity.
- Have diabetes mellitus.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
- For the GOA1 Sub-study:
- Have had steroid joint injections within 90 days of screening.
- Have had other joint injections and procedures within 6 months of screening.
- Have joint disease other than osteoarthritis.
- For the GSA1 Sub-study:
- Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
- Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
- Use a dental appliance or other device to treat OSA other than PAP therapy.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.