A Study of LY3437943 in Participants Who Have Obesity or Overweight (TRIUMPH-1)

Phase 3

Active, not recruiting

• Conditions: Obesity; Osteoarthritis, Knee; Overweight

• Registration Number: 2023-503657-35-00
• Lead Sponsor: Eli Lilly & Co.

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Posted: 2023-09-28
• Last Update Posted: 2025-06-17

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Not specified
• Target Recruitment: 440

Inclusion Criteria

Be overweight

Have history of unsuccessful dietary weight loss effort

(GOA1) Have index knee pain for >12 weeks prior to screening and at least one of the following (GOA1) Age >50 years (GOA1) Morning stiffness in the index knee less than 30 minutes in duration (GOA1) Crepitus in the index knee

Exclusion Criteria

Have a self-reported or documented change in body weight > 5kg within 90 days prior to screening

(GOA1) Pain from another location with radiation to the knee (for example, hip pain referred to the knee, radicular pain)

(GOA1) Knee infection

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent Change from Baseline in Body Weight		Percent Change from Baseline in Body Weight
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset		Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset

Trial Locations

Locations (36)

University Of Debrecen; 🇭🇺 Debrecen, Hungary

Regia Med Kft.; 🇭🇺 Szekesfehervar, Hungary

DRC Kft.; 🇭🇺 Balatonfured, Hungary

Clindiab Kft.; 🇭🇺 Budapest XVIII, Hungary

Obudai Egeszsegugyi Centrum Kft.; 🇭🇺 Budapest III, Hungary

University Of Szeged; 🇭🇺 Szeged, Hungary

Medifarma-98 Kft.; 🇭🇺 Nyiregyhaza, Hungary

Centrum Badan Klinicznych Pi-House Sp. z o.o.; 🇵🇱 Gdansk, Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski; 🇵🇱 Poznan, Poland

Centrum Medyczne Intercor Sp. z o.o.; 🇵🇱 Bydgoszcz, Poland

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University Of Debrecen

🇭🇺Debrecen, Hungary

Denes Pall

Site contact

36309657913

pall.denes@gmail.com

Gizella Petro

Site contact

3652511828

petrogizi@gmail.com