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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05931367
Collaborator
(none)
405
Enrollment
68
Locations
3
Arms
26.9
Anticipated Duration (Months)
6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
405 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Oct 6, 2025
Anticipated Study Completion Date :
Nov 2, 2025

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score [Baseline, Week 68]

    2. Percent Change from Baseline in Body Weight [Baseline, Week 68]

    Secondary Outcome Measures

    1. Change from Baseline in the WOMAC Physical Function Subscale Score [Baseline, Week 68]

    2. Change from Baseline in Waist Circumference [Baseline, Week 68]

    3. Percent Change from Baseline in Total Cholesterol [Baseline, Week 68]

    4. Percent Change from Baseline in Triglycerides [Baseline, Week 68]

    5. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 68]

    6. Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 68]

    7. Change from Baseline in Diastolic Blood Pressure (DBP) [Baseline, Week 68]

    8. Percent Change from Baseline in Fasting Insulin [Baseline, Week 68]

    9. Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [Baseline, Week 68]

    10. Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score [Baseline, Week 68]

    11. Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score [Baseline, Week 68]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Research Center Phoenix Arizona United States 85053
    2 Artemis Institute for Clinical Research San Diego California United States 92103
    3 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    4 Suncoast Research Group Miami Florida United States 33135
    5 North Georgia Clinical Research Woodstock Georgia United States 30189
    6 Elite Clinical Trials Blackfoot Idaho United States 83221
    7 Northwestern University Chicago Illinois United States 60611
    8 MedVadis Research Corporation Waltham Massachusetts United States 02451
    9 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
    10 Clinvest Research LLC Springfield Missouri United States 65807
    11 Mercy Family Clinic Dallas Texas United States 75211
    12 Clinical Trials of Texas, Inc. San Antonio Texas United States 78229
    13 Northwest Clinical Research Center Bellevue Washington United States 98007
    14 Paratus Clinical Research Canberra Bruce Australian Capital Territory Australia 2617
    15 Paratus Clinical Research Western Sydney Blacktown New South Wales Australia 2148
    16 Emeritus Research Botany New South Wales Australia 2019
    17 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
    18 Core Research Group Brisbane Queensland Australia 4064
    19 CDH Research Institute Maroochydore Queensland Australia 4558
    20 Emeritus Research Camberwell Victoria Australia 3124
    21 Barwon Health Geelong Victoria Australia 3220
    22 Advara HeartCare Joondalup Joondalup Western Australia Australia 6027
    23 C-health Research Calgary Alberta Canada T2V 4J2
    24 Eastern Health - General Hospital St. John's Newfoundland and Labrador Canada A1B 3V6
    25 Viable Clinical Research Bridgewater Nova Scotia Canada B4V 3N2
    26 Bluewater Clinical Research Group Inc. Sarnia Ontario Canada N7T 4X3
    27 Viable Clinical Research Scarborough Ontario Canada M1P 2T7
    28 Stouffville Medical Centre Stouffville Ontario Canada L4A 1H2
    29 Private Practice - Dr. Pierre Bonin Sudbury Ontario Canada P3A 1Y8
    30 Canadian Phase Onward Toronto Ontario Canada M3J 0K2
    31 Alpha Recherche Clinique Quebec Canada G2J 0C4
    32 ALPHA Recherche Clinique Quebec Canada G3K 2P8
    33 Chinese PLA General Hospital Beijing Beijing China 100853
    34 Shunde Hospital of Southern Medical Univesity Foshan Guangdong China 528399
    35 Cangzhou People's Hospital Medical College Cangzhou Hebei China 061600
    36 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    37 Baotou Central Hospital Baotou Inner Mongolia China 014040
    38 Nanjing First Hospital Nanjing Jiangsu China 210006
    39 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    40 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    41 The First Hospital of Jilin University Changchun Jilin China 130021
    42 The Fourth Hospital of Harbin Medical University Harbin Nangang District China 150001
    43 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China 710077
    44 Jinan Central Hospital Jinan Shandong China 250013
    45 Shanghai Minhang District Central Hospital Shanghai Shanghai China 201199
    46 Jiading District Central Hospital Shanghai Shanghai China 201800
    47 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    48 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    49 The First People's Hospital of Yunnan Province Kunming Yunnan China 650034
    50 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China 310014
    51 Consultorio Médico Guadalajara Jalisco Mexico 44210
    52 IMED Internal Medicine Clin Trials Monterrey Nuevo León Mexico 64060
    53 Clínica García Flores SC Monterrey Nuevo León Mexico 64610
    54 Unidad Médica para la Salud Integral San Nicolás de los Garza Nuevo León Mexico 66465
    55 Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C. Ciudad Madero Tamaulipas Mexico 89440
    56 Köhler & Milstein Research Mérida Yucatán Mexico 97070
    57 Investigacion y Biomedicina de Chihuahua Chihuahua Mexico 31000
    58 CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña] Spain 15006
    59 Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol A Coruña [La Coruña] Spain 15405
    60 Hu Reina Sofia Cordoba Andalucía Spain 14004
    61 Hospital Quirón Málaga Málaga Andalucía Spain 29004
    62 Hospital de la Santa Creu i Sant Pau Barcelona Catalunya [Cataluña] Spain 08041
    63 Hospital Universitario Infanta Sofía San Sebastián de Los Reyes Madrid, Comunidad De Spain 28702
    64 Hospital General Universitario de Valencia Valencia Valenciana, Comunitat Spain 46014
    65 Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Sevilla Spain 41003
    66 Leicester General Hospital Leicester Leicestershire United Kingdom LE5 4PW
    67 Panthera Biopartners - North London Enfield Town London, City Of United Kingdom EN3 4GS
    68 Panthera Biopartners - Sheffield Sheffield United Kingdom S2 5FX

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05931367
    Other Study ID Numbers:
    • 18583
    • J1I-MC-GZBN
    • 2023-503660-17-00
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Obesity
    Overweight

    Study Results

    No Results Posted as of Jul 11, 2023