Clinical trial NCT05929079: A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Obesity
Overweight
Obstructive Sleep Apnea
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 80
measure: Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
timeFrame: Baseline, Week 80
Secondary outcomes:
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 80
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 80
measure: Change from Baseline in Hemoglobin (A1c) HbA1c %
timeFrame: Baseline, Week 80
measure: Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
timeFrame: Baseline, Week 80
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, Week 80
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
timeFrame: Baseline through Week 80
measure: Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
timeFrame: Baseline, Week 80
measure: 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
timeFrame: Baseline to Week 80
measure: Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset
timeFrame: Baseline to Week 80
measure: Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset
timeFrame: Week 80
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Little Rock
country: United States
facility: Preferred Research Partners
state: Arkansas
city: Cerritos
country: United States
facility: Core Healthcare Group
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Boca Raton
country: United States
facility: Excel Medical Clinical Trials
state: Florida
city: Brandon
country: United States
facility: Teradan Clinical Trials, LLC
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners LLC, dba Flourish Research
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research Inc
state: Georgia
city: Rincon
country: United States
facility: Centricity Research Rincon Pulmonology
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Indianapolis
country: United States
facility: Brengle Family Medicine
state: Indiana
city: Waltham
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: New Windsor
country: United States
facility: Mid Hudson Medical Research
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Spartanburg
country: United States
facility: Tribe Clinical Research - Spartanburg
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Santa Rosa
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
state: La Pampa
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Macquarie Park
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
city: Merewether
country: Australia
facility: The AIM Centre / Hunter Diabetes Centre
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Core Research Group
state: Queensland
city: Adelaide
country: Australia
facility: Nightingale Research
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders University
state: South Australia
city: Oaklands Park
country: Australia
facility: Southern Adelaide Diabetes & Endocrine Services
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Joondalup
country: Australia
facility: Advara HeartCare Joondalup
state: Western Australia
city: Sao Paulo
country: Brazil
facility: BR Trials - Ensaios Clinicos e Consultoria
state: São Paulo
city: São Paulo
country: Brazil
facility: CPQuali Pesquisa Clínica
city: São Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigação Clínica
city: Raipur
country: India
facility: All India Institute of Medical Sciences
state: Chhattisgarh
city: Ahmedabad
country: India
facility: V.S. General Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: Avron Hospitals
state: Gujarat
city: Ahmedabad
country: India
facility: Zydus Hospitals & Healthcare Research Pvt.Ltd.
state: Gujarat
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Hubli
country: India
facility: Sushruta Multispeciality Hospital & Research Centre
state: Karnataka
city: Mysore
country: India
facility: Mysore Medical College
state: Karnataka
city: Indore
country: India
facility: CARE CHL-Hospitals
state: Madhya Pradesh
city: Jaipur
country: India
facility: Sawai Man Singh Medical College Hospital (SMS Hospital)
state: Rajasthan
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Vellore
country: India
facility: Christian Medical College Vellore
state: Tamil Nadu
city: Hyderabad
country: India
facility: Care Hospitals Hyderabad- Banjara Hills
state: Telangana
city: Hyderabad
country: India
facility: Diabetes Research Center
state: Telangana
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
state: West Bengal
city: Mexicali
country: Mexico
facility: Centro de Investigacion en Artritis y Osteoporosis SC
state: Baja California
city: Mexico City
country: Mexico
facility: RM Pharma Specialists
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Clinica Omega
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica
state: Jalisco
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA
state: Jalisco
city: Monterrey
country: Mexico
facility: Cardiolink Clin Trials
state: Nuevo León
city: Monterrey
country: Mexico
facility: Unidad biomedica avanzada monterrey
state: Nuevo León
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Oradea
country: Romania
facility: Diabdana
state: Bihor
city: Bucharest
country: Romania
facility: Geea Medical Easy Diet
state: București
city: Bucharest
country: Romania
facility: Centrul Medical NutriLife
state: București
city: Mangalia
country: Romania
facility: Gama Diamed
state: Constanța
city: Târgu-Mureș
country: Romania
facility: Centrul Medical Mediab
state: Mureș
city: Bacău
country: Romania
facility: CMI Dr.Pletea Noemi SRL
city: Almeria
country: Spain
facility: Centro Periférico de Especialidades Bola Azul
state: Almería
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Málaga
country: Spain
facility: H.R.U Málaga - Hospital Civil
state: Andalucía
city: León
country: Spain
facility: Complejo Asistencial Universitario de León - Hospital de León
state: Castilla Y León
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Seville
country: Spain
facility: Vithas Hospital Sevilla
state: Sevilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Del Rocio
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: