A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight | NCT05929066 | Trialant

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight | NCT05929066 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: 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 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 OSA)

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.

GZBJ Addenda (2) inclusion criteria:

Have completed the final treatment visit of GZBJ Week 80.

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.

GZBJ Addenda (2) exclusion criteria

Have had study intervention discontinuation.

Have had permanent dose reduction.