Vanderbilt Clinical Trials

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

Purpose

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. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

Conditions

Obesity
Overweight
Osteoarthritis, Knee
Obstructive Sleep Apnea

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 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.

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Retatrutide Dose 1	Participants will receive retatrutide subcutaneously (SC).	Drug: Retatrutide Administered SC Other names: LY3437943
Experimental Retatrutide Dose 2	Participants will receive retatrutide SC.	Drug: Retatrutide Administered SC Other names: LY3437943
Experimental Retatrutide Dose 3	Participants will receive retatrutide SC.	Drug: Retatrutide Administered SC Other names: LY3437943
Placebo Comparator Placebo	Participants will receive placebo.	Drug: Placebo Administered SC
Experimental Retatrutide Extension Period	Participants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.	Drug: Retatrutide Administered SC Other names: LY3437943

More Details

Status: Active, not recruiting
Sponsor: Eli Lilly and Company

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.