A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Obesity; Osteo Arthritis Knee

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05931367

2023-503660-17-00 (Other Identifier)

J1I-MC-GZBN (Other Identifier)

18583

Details and patient eligibility

About

The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.

Enrollment: 405 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
• 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.

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.
• Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days prior to screening.
• Have been taking 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

405 participants in 3 patient groups, including a placebo group

Retatrutide Dose 1

Experimental group

Description:

Participants will receive retatrutide subcutaneously (SC).

Treatment:

Drug: Retatrutide

Retatrutide Dose 2

Experimental group

Description:

Participants will receive retatrutide SC.

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo