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

Obesity Clinical Trial

— TRIUMPH-4  

Official title:

A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931367
• Other study ID #: 18583
• Secondary ID: J1I-MC-GZBN2023-
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: March 8, 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: March 8, 2026
• Est. primary completion date: February 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee
• Overweight

Intervention

Drug:
• Retatrutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Western Sydney	Blacktown	New South Wales
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Core Research Group	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Paratus Clinical Research Canberra	Bruce	Australian Capital Territory
Australia	Emeritus Research	Camberwell	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Coastal Digestive Health	Maroochydore	Queensland
Canada	Viable Clinical Research	Bridgewater	Nova Scotia
Canada	C-health Research	Calgary	Alberta
Canada	Wharton Medical Clinic	Hamilton	Ontario
Canada	Alpha Recherche Clinique	Quebec
Canada	ALPHA Recherche Clinique	Quebec
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Viable Clinical Research	Scarborough	Ontario
Canada	Eastern Health - General Hospital	St. John's	Newfoundland and Labrador
Canada	Stouffville Medical Centre	Stouffville	Ontario
Canada	Canadian Phase Onward	Toronto	Ontario
Mexico	Investigacion y Biomedicina de Chihuahua	Chihuahua
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares	Ciudad Madero	Tamaulipas
Mexico	Consultorio Médico	Guadalajara	Jalisco
Mexico	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Clínica García Flores SC	Monterrey	Nuevo León
Mexico	IMED Internal Medicine Clin Trials	Monterrey	Nuevo León
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval")	Ferrol	A Coruña [La Coruña]
Spain	Hospital Quirón Málaga	Málaga
Spain	Hospital Universitario Infanta Sofía	San Sebastián de Los Reyes	Madrid, Comunidad De
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia	Valenciana, Comunitat
United Kingdom	Panthera Biopartners - North London	Enfield	London, City Of
United Kingdom	Leicester General Hospital	Leicester	Leicestershire
United Kingdom	Panthera Biopartners - Sheffield	Sheffield
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Northwestern University	Chicago	Illinois
United States	Mercy Family Clinic	Dallas	Texas
United States	Suncoast Research Group	Miami	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Clinvest Research LLC	Springfield	Missouri
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	North Georgia Clinical Research	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Mexico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score		Baseline, Week 68
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 68
Secondary	Change from Baseline in the WOMAC Physical Function Subscale Score		Baseline, Week 68
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 68
Secondary	Percent Change from Baseline in Total Cholesterol		Baseline, Week 68
Secondary	Percent Change from Baseline in Triglycerides		Baseline, Week 68
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 68
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 68
Secondary	Change from Baseline in Diastolic Blood Pressure (DBP)		Baseline, Week 68
Secondary	Percent Change from Baseline in Fasting Insulin		Baseline, Week 68
Secondary	Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score		Baseline, Week 68
Secondary	Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score		Baseline, Week 68
Secondary	Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score		Baseline, Week 68

External Links

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