A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Obesity Clinical Trial

— TRIUMPH-2  

Official title:

A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929079
• Other study ID #: 18558
• Secondary ID: J1I-MC-GZBKJ1I-M
• Status: Recruiting
• Phase: Phase 3
• Start date: July 11, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: June 1, 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 purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2026
• Est. primary completion date: May 3, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)

• Have Type 2 Diabetes (T2D)

• Are on stable treatment for T2D for at least 90 days

• Have a history of at least one unsuccessful dietary effort to lose body weight.

GSA2 Inclusion Criteria

• Previously diagnosed with OSA

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

• 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 Type 1 diabetes

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

• Have had pancreatitis

GSA2 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

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Obstructive Sleep Apnea
• Overweight
• Sleep Apnea, Obstructive
• Type 2 Diabetes

Intervention

Drug:
• Retatrutide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Argentina	Centro Médico Viamonte	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada	Ciudad Autonoma de Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Centro de Salud e Investigaciones Médicas	Santa Rosa	La Pampa
Australia	Nightingale Research	Adelaide	South Australia
Australia	Flinders University	Bedford Park	South Australia
Australia	Optimus Clinical Research	Botany	New South Wales
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Core Research Group	Brisbane	Queensland
Australia	Royal Brisbane and Women's Hospital	Brisbane	Queensland
Australia	Emeritus Research	Camberwell	Victoria
Australia	Austin Health - Repatriation Hospital	Heidelberg West	Victoria
Australia	GenesisCare	Joondalup	Western Australia
Australia	The AIM Centre / Hunter Diabetes Centre	Merewether	New South Wales
Australia	Southern Adelaide Diabetes & Endocrine Services	Oaklands Park	South Australia
Australia	Woolcock Institute of Medical Research	Sydney	New South Wales
Brazil	BR Trials - Ensaios Clinicos e Consultoria	Sao Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	CPQuali Pesquisa Clínica	São Paulo
India	Avron Hospitals	Ahmedabad	Gujarat
India	V.S. General Hospital	Ahmedabad	Gujarat
India	Zydus Hospitals & Healthcare Research Pvt.Ltd.	Ahmedabad	Gujarat
India	Life Care Hospital and Research Centre	Bangalore	Karnataka
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Sushruta Multispeciality Hospital & Research Centre	Hubli	Karnataka
India	Care Hospitals Hyderabad- Banjara Hills	Hyderabad	Telangana
India	Kumudini Devi Diabetes Research Center	Hyderabad	Telangana
India	CARE CHL-Hospitals	Indore	Madhya Pradesh
India	Sawai Man Singh Medical College Hospital (SMS Hospital)	Jaipur	Rajasthan
India	Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital	Kolkata	West Bengal
India	Mysore Medical College	Mysore	Karnataka
India	All India Institute of Medical Sciences	Raipur	Chhattisgarh
India	Christian Medical College Vellore	Vellore	Tamil Nadu
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	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	Kohler and Milstein Research S.A. de C.V.	Mérida	Yucatán
Mexico	Centro de Investigacion en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares	Mexico City	Distrito Federal
Mexico	Clinica Omega	Mexico City	Distrito Federal
Mexico	RM Pharma Specialists	Mexico City	Distrito Federal
Mexico	Cardiolink Clin Trials	Monterrey	Nuevo León
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
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Romania	CMI Dr.Pletea Noemi SRL	Bacau
Romania	Centrul Medical NutriLife	Bucharest	Bucure?ti
Romania	Geea Medical Easy Diet	Bucharest	Bucure?ti
Romania	Gama Diamed	Mangalia	Constan?a
Romania	Diabdana	Oradea	Bihor
Romania	Centrul Medical Mediab	Târgu-Mure?	Mure?
Spain	Centro Periférico de Especialidades Bola Azul	Almeria	Almería
Spain	Complejo Asistencial Universitario de León - Hospital de León	León	Castilla Y León
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucía
Spain	H.R.U Málaga - Hospital Civil	Málaga	Andalucía
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Vithas Hospital Sevilla	Seville	Sevilla
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Chung Shan Medical University Hospital	Taichung City	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei City	Taipei
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	NeuroTrials Research Inc	Atlanta	Georgia
United States	FutureSearch Trials of Neurology	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Excel Medical Clinical Trials	Boca Raton	Florida
United States	Teradan Clinical Trials, LLC	Brandon	Florida
United States	Core Healthcare Group	Cerritos	California
United States	CTI-CRC	Cincinnati	Ohio
United States	Intrepid Research	Cincinnati	Ohio
United States	Cullman Clinical Trials	Cullman	Alabama
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Lillestol Research	Fargo	North Dakota
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Brengle Family Medicine	Indianapolis	Indiana
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	Preferred Research Partners	Little Rock	Arkansas
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Clinical Site Partners LLC, dba Flourish Research	Miami	Florida
United States	Quantum Clinical Trials	Miami Beach	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	Mid Hudson Medical Research	New Windsor	New York
United States	Valley Clinical Trials, Inc.	Northridge	California
United States	Renstar Medical Research	Ocala	Florida
United States	Advanced Research Institute	Ogden	Utah
United States	Office 18	Pittsburgh	Pennsylvania
United States	Clinical Research Center of Florida	Pompano Beach	Florida
United States	Centricity Research Rincon Pulmonology	Rincon	Georgia
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Tribe Clinical Research - Spartanburg	Spartanburg	South Carolina
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	MedVadis Research Corporation	Waltham	Massachusetts
United States	Chase Medical Research, LLC	Waterbury	Connecticut
United States	Palm Beach Research Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  India,  Mexico,  Romania,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 80
Primary	Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 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	Change from Baseline in Diastolic Blood Pressure (DBP)		Baseline, Week 80
Secondary	Percent Change from Baseline in Total Cholesterol		Baseline, Week 80
Secondary	Percent Change from Baseline in Triglycerides		Baseline, Week 80
Secondary	Change from Baseline in Hemoglobin (A1c) 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	Change from Baseline in Fasting Glucose		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	Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 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 GSA2 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 component.	Baseline to Week 80
Secondary	Percentage of Participants with =50% AHI Reduction from Baseline for GSA2 Subset		Baseline to Week 80
Secondary	Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10 for GSA2 Subset		Week 80

External Links

•   A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2)