Overview
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits.
Eligibility
Inclusion Criteria:
- Have 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
- History of of at least one unsuccessful dietary effort to reduce body weight
GOA1 Inclusion Criteria:
- 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.
GSA1 Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
GOA1 exclusion criteria
- 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.
GSA1 exclusion criteria
- 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.