A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Obesity Clinical Trial

— TRIUMPH-1  

Official title:

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929066
• Other study ID #: 18557
• Secondary ID: J1I-MC-GZBJJ1I-M
• Status: Recruiting
• Phase: Phase 3
• Start date: July 10, 2023
• Est. completion date: May 13, 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: 317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: May 13, 2026
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have body mass index (BMI) =30.0 kilograms per square meter (kg/m²), or =27.0 kg/m² with at least one of the following:

• hypertension

• dyslipidemia

• obstructive sleep apnea, or

• cardiovascular disease

• History of of at least one unsuccessful dietary effort to reduce body weight

GOA1 Inclusion Criteria:

• 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.

GSA1 Inclusion Criteria:

• Previously diagnosed with OSA

• Have AHI =15 on polysomnography at screening (definition of moderate-to-severe OS)

• For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.

• If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

Exclusion Criteria:

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

• Have taken 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.

• Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

• Have had pancreatitis.

GOA1 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.

GSA1 exclusion criteria

• Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.

• Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.

• Use a dental appliance or other device to treat OSA other than PAP therapy.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Pain Chronic
• Obesity
• Obstructive Sleep Apnea
• Overweight
• Sleep Apnea, Obstructive

Intervention

Drug:
• Retatrutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Australia	Fusion Clinical Research	Adelaide	South Australia
Australia	Nightingale Research	Adelaide	South Aust
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Emeritus Research	Camberwell	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Logan Hospital	Meadowbrook	Queensland
Australia	The AIM Centre / Hunter Diabetes Centre	Merewether	New South Wales
Australia	One Clinical Research	Nedlands	Western Australia
Brazil	CPCLIN	Sao Paulo	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
Canada	Aggarwal and Associates Limited	Brampton	Ontario
Canada	Dr. Steven V. Zizzo Medicine Professional Corporation	Hamilton	Ontario
Canada	Wharton Medical Clinic	Hamilton	Ontario
Canada	Centre de Recherche Clinique de Laval	Laval	Quebec
Canada	Clinique de médecine Urbaine du Quartier Latin	Montreal	Quebec
Canada	Your Research Network	Niagara Falls	Ontario
Canada	Bluewater Clinical Research Group Inc.	Sarnia	Ontario
Canada	Canadian Phase Onward	Toronto	Ontario
Canada	C.I.C. Mauricie inc.	Trois-Rivières	Quebec
Hungary	DRC Gyógyszervizsgáló Központ	Balatonfüred	Veszprém
Hungary	ClinDiab Kft.	Budapest
Hungary	Óbudai Egészségügyi Centrum	Budapest
Hungary	Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház	Debrecen
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Medifarma 98 Kft	Nyiregyhaza	Nyíregyháza
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád
Hungary	Regia Med Kft	Szekesfehervar	Fejér
India	Avron Hospitals	Ahmedabad	Gujarat
India	All India Institute of Medical Sciences	Bhubaneswar	Odisha
India	Endolife Speciality Hospitals	Guntur	Andhra Pradesh
India	Karnataka Institute of Medical Sciences	Hubli	Karnataka
India	Eternal Heart Care Center and Research Institute	Jaipur	Rajasthan
India	ILS Hospitals	Kolkata	West Benga
India	Wockhardt Hospital - Mumbai Central	Mumbai	Maharashtra
India	Central India Cardiology and Research Institute	Nagpur	Maharashtra
India	All India Institute of Medical Sciences	New Delhi	Delhi
India	Chellaram Diabetes Institute	Pune	Maharashtra
India	Deenanath Mangeshkar Hospital & Research Centre	Pune	Maharashtra
India	Lifepoint Multispeciality Hospital	Pune	Maharashtra
India	Surat Institute of Digestive Sciences Hospitals	Surat	Gujarat
India	Indian Institute of Diabetes	Thiruvananthapuram	Kerala
India	Jothydev's Diabetes and Research Center	Trivandrum	Kerala
India	Christian Medical College Vellore	Vellore	Tamil Nadu
Mexico	Centro de Atención e Investigación Clínica	Aguascalientes
Mexico	Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos	Chihuahua
Mexico	Instituto de Diabetes, Obesidad y Nutricion	Cuernavaca	Morelos
Mexico	Clinica de Investigacion en Reumatologia y Obesidad S. C.	Guadalajara	Jalisco
Mexico	Diseno y Planeacion en Investigacion Medica	Guadalajara	Jalisco
Mexico	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco
Mexico	EME RED Hospitalaria	Mérida	Yucatán
Mexico	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Centro de Investigacion en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Clinica Omega	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Hospital Universitario Dr. Jose Eleuterio Gonzalez	Monterrey	Nuevo León
Mexico	Unidad biomedica avanzada monterrey	Monterrey	Nuevo León
Mexico	Arké SMO S.A de C.V	Veracruz
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	INTERCOR	Bydgoszcz	Kujawsko-pomorskie
Poland	Ambulatorium Barbara Bazela	Elblag	Warminsko-mazurskie
Poland	Centrum Kliniczno-Badawcze	Elblag	Warminsko-mazurskie
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk	Pomorskie
Poland	NZOZ Salvia CM	Katowice	Slaskie
Poland	Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci	Kielce	Swietokrzyskie
Poland	CenterMed Lublin NZOZ	Lublin	Lubelskie
Poland	Gabinety TERPA	Lublin	Lubelskie
Poland	Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan	Wielkopolskie
Poland	Private Practice - Dr. Robert Witek	Tarnów	Malopolskie
Poland	Medycyna Kliniczna	Warszawa	Mazowieckie
Puerto Rico	Ponce Medical School Foundation Inc.	Ponce
Romania	SC Minimed SRL	Bacau
Romania	C.M.D.T.A. Neomed	Brasov	Bra?ov
Romania	Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului	Bucharest	Bucure?ti
Romania	Diamed Obesity	Gala?i
Romania	Centrul Medical Consultmed	Ia?i
Romania	Gama Diamed	Mangalia	Constan?a
Romania	Diabdana	Oradea	Bihor
Romania	Clinica Korall	Satu Mare
Romania	Policlinica Astra Sibiu	Sibiu
Romania	Cabinet Medical Dr.Geru	Timisoara	Timi?
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [Barcelona]
Spain	Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval	Ferrol	A Coruña [La Coruña]
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia	Valenciana, Comunitat
Taiwan	Changhua Christian Hospital	Changhua County	Changhua
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
United Kingdom	Heartlands Hospital	Birmingham
United Kingdom	Layton Medical Centre	Blackpool	Lancashire
United Kingdom	Rowden Surgery	Chippenham	England
United Kingdom	Panthera Biopartners - North London	Enfield	London, City Of
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland
United Kingdom	Leicester General Hospital	Leicester	Leicestershire
United Kingdom	Aintree University Hospital NHS Foundation Trust	Liverpool
United Kingdom	St Clare Medical Centre	Penzance
United Kingdom	Panthera Biopartners - Sheffield	Sheffield
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Teradan Clinical Trials, LLC	Brandon	Florida
United States	Northwestern University	Chicago	Illinois
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	Lillestol Research	Fargo	North Dakota
United States	Valley Research	Fresno	California
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Juno Research	Houston	Texas
United States	Brengle Family Medicine	Indianapolis	Indiana
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Medical Investigations	Little Rock	Arkansas
United States	New Horizon Research Center	Miami	Florida
United States	Suncoast Research Group	Miami	Florida
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Vanderbilt Health One Hundred Oaks	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Advanced Research Institute	Ogden	Utah
United States	Clinical Neuroscience Solutions	Orlando	Florida
United States	Arizona Research Center	Phoenix	Arizona
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Artemis Institute for Clinical Research	San Diego	California
United States	Tribe Clinical Research - Spartanburg	Spartanburg	South Carolina
United States	Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative	Springfield	Illinois
United States	Clinvest Research LLC	Springfield	Missouri
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Trial Management Associates - Wilmington - Floral Parkway	Wilmington	North Carolina
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,  Brazil,  Canada,  Hungary,  India,  Mexico,  Poland,  Puerto Rico,  Romania,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight		Baseline, Week 80
Primary	Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset		Baseline, Week 80
Primary	Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset		Baseline, Week 80
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 80
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 80
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 80
Secondary	Percent Change form Baseline in Fasting Insulin		Baseline, Week 80
Secondary	Change from Baseline in HbA1c		Baseline, Week 80
Secondary	Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score		Baseline, Week 80
Secondary	Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)	AUC is presented as a single average measure of AUC across the study duration.	Baseline through Week 80
Secondary	Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset		Baseline, Week 80
Secondary	Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset		Baseline, Week 80
Secondary	Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset		Baseline, Week 80
Secondary	Percent Change from Baseline in AHI for GSA1 Subset		Baseline, Week 80
Secondary	A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset	A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.	Baseline to Week 80
Secondary	Percentage of Participants with =50% AHI Reduction from Baseline for GSA1 Subset		Baseline to Week 80
Secondary	Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10 for GSA1 Subset		Week 80

External Links

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