The trial is taking place at:
C

Chase Medical Research, LLC | Waterbury, MA

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

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Lilly

Status and phase

Enrolling
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

Trial contacts and locations

49

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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