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

Primary Purpose

Type 2 Diabetes, Obesity, Overweight

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Retatrutide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Research Institute - WilshireRecruiting
  • Valley Clinical Trials, Inc.Recruiting
  • Diablo Clinical Research, Inc.Recruiting
  • Chase Medical Research, LLCRecruiting
  • Teradan Clinical Trials, LLCRecruiting
  • Renstar Medical ResearchRecruiting
  • Palm Beach Research CenterRecruiting
  • NeuroTrials Research IncRecruiting
  • East-West Medical Research InstituteRecruiting
  • Brengle Family MedicineRecruiting
  • MedVadis Research CorporationRecruiting
  • StudyMetrix ResearchRecruiting
  • Las Vegas Medical ResearchRecruiting
  • Carteret Medical GroupRecruiting
  • Lillestol ResearchRecruiting
  • CTI-CRCRecruiting
  • Office 18Recruiting
  • Tribe Clinical Research, LLCRecruiting
  • Trial Management AssociatesRecruiting
  • Tribe Clinical Research - SpartanburgRecruiting
  • FutureSearch Trials of NeurologyRecruiting
  • Dallas Diabetes Research CenterRecruiting
  • Advanced Research InstituteRecruiting
  • Centro Médico Viamonte
  • Consultorio de Investigación Clínica EMO SRL
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
  • Centro de Salud e Investigaciones Médicas
  • The AIM Centre / Hunter Diabetes CentreRecruiting
  • Woolcock Institute of Medical ResearchRecruiting
  • Royal Brisbane and Women's HospitalRecruiting
  • Core Research GroupRecruiting
  • Nightingale ResearchRecruiting
  • Southern Adelaide Diabetes & Endocrine ServicesRecruiting
  • Flinders UniversityRecruiting
  • Box Hill HospitalRecruiting
  • Austin Health - Repatriation HospitalRecruiting
  • GenesisCareRecruiting
  • The Second Affiliated Hospital of Zhengzhou University
  • Baotou Central Hospital
  • Nanjing First Hospital
  • The Second Affiliated Hospital of Nanjing Medical University
  • The First Hospital of Jilin University
  • The First Affiliated Hospital of Xi'an Medical University
  • Pudong New Area People's Hospital Shanghai
  • West China Hospital of Sichuan University
  • Ningbo First Hospital
  • V.S. General Hospital
  • Avron Hospitals
  • Zydus Hospitals & Healthcare Research Pvt.Ltd.
  • Life Care Hospital and Research CentreRecruiting
  • Sushruta Multispeciality Hospital & Research Centre
  • CHL Hospital IndoreRecruiting
  • Sawai Man Singh Medical College Hospital (SMS Hospital)
  • Madras Diabetes Research Foundation
  • Christian Medical College Vellore
  • Care Hospitals Hyderabad- Banjara HillsRecruiting
  • Kumudini Devi Diabetes Research Center
  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
  • Korea University Ansan HospitalRecruiting
  • Hanyang University Guri HospitalRecruiting
  • Yeungnam Univeristy Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health System
  • Ulsan University Hospital
  • Centro de Investigacion en Artritis y Osteoporosis SC
  • RM Pharma Specialists
  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
  • Diseno y Planeacion en Investigacion Medica
  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
  • Unidad de Investigación Clínica y Atención Médica HEPA
  • Cardiolink Clin Trials
  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
  • FAICIC S. de R.L. de C.V.
  • Arké SMO S.A de C.V
  • DiabdanaRecruiting
  • Geea Medical Easy DietRecruiting
  • Centrul Medical NutriLifeRecruiting
  • Gama DiamedRecruiting
  • Centrul Medical MediabRecruiting
  • CMI Dr.Pletea Noemi SRLRecruiting
  • Centro Periférico de Especialidades Bola AzulRecruiting
  • Hospital Universitario Virgen de la VictoriaRecruiting
  • Complejo Asistencial Universitario de León - Hospital de LeónRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Vithas Hospital SevillaRecruiting
  • Hospital Universitario Virgen Del RocioRecruiting
  • Chang Gung Memorial Hospital at Kaohsiung
  • Chung Shan Medical University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Retatrutide Dose 1

Retatrutide Dose 2

Retatrutide Dose 3

Placebo

Arm Description

Participants will receive retatrutide subcutaneously (SC).

Participants will receive retatrutide SC.

Participants will receive retatrutide SC.

Participants will receive placebo.

Outcomes

Primary Outcome Measures

Percent Change from Baseline in Body Weight
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

Secondary Outcome Measures

Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Waist Circumference
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in Diastolic Blood Pressure (DBP)
Percent Change from Baseline in Total Cholesterol
Percent Change from Baseline in Triglycerides
Change from Baseline in Hemoglobin (A1c) HbA1c %
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Change from Baseline in Fasting Glucose
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.
Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
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.
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset

Full Information

First Posted
June 26, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT05929079
Brief Title
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2023 (Actual)
Primary Completion Date
May 3, 2026 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity, Overweight, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retatrutide Dose 1
Arm Type
Experimental
Arm Description
Participants will receive retatrutide subcutaneously (SC).
Arm Title
Retatrutide Dose 2
Arm Type
Experimental
Arm Description
Participants will receive retatrutide SC.
Arm Title
Retatrutide Dose 3
Arm Type
Experimental
Arm Description
Participants will receive retatrutide SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Retatrutide
Other Intervention Name(s)
LY3437943
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 80
Title
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time Frame
Baseline, Week 80
Secondary Outcome Measure Information:
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 80
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 80
Title
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 80
Title
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame
Baseline, Week 80
Title
Percent Change from Baseline in Total Cholesterol
Time Frame
Baseline, Week 80
Title
Percent Change from Baseline in Triglycerides
Time Frame
Baseline, Week 80
Title
Change from Baseline in Hemoglobin (A1c) HbA1c %
Time Frame
Baseline, Week 80
Title
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time Frame
Baseline, Week 80
Title
Change from Baseline in Fasting Glucose
Time Frame
Baseline, Week 80
Title
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Description
AUC is presented as a single average measure of AUC across the study duration.
Time Frame
Baseline through Week 80
Title
Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time Frame
Baseline, Week 80
Title
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
Description
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.
Time Frame
Baseline to Week 80
Title
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset
Time Frame
Baseline to Week 80
Title
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset
Time Frame
Week 80

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
213-483-1800
First Name & Middle Initial & Last Name & Degree
David Guzman
Facility Name
Valley Clinical Trials, Inc.
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Chow
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
925-930-7267
First Name & Middle Initial & Last Name & Degree
Helen L Stacey
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-419-4420
First Name & Middle Initial & Last Name & Degree
Joseph Soufer
Facility Name
Teradan Clinical Trials, LLC
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
813-758-6613
First Name & Middle Initial & Last Name & Degree
Daniel G. Lorch
Facility Name
Renstar Medical Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
352-629-5800
First Name & Middle Initial & Last Name & Degree
Raj Karunakara
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
561-689-0606
First Name & Middle Initial & Last Name & Degree
Mira Baron
Facility Name
NeuroTrials Research Inc
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
404-851-9934
First Name & Middle Initial & Last Name & Degree
Russell P. Rosenberg
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
8085316886
First Name & Middle Initial & Last Name & Degree
Cindy H. T. Pau
Facility Name
Brengle Family Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blair Brengle
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-744-1310
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
StudyMetrix Research
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
636-387-5100
First Name & Middle Initial & Last Name & Degree
Timothy R Smith
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
702-750-0222
First Name & Middle Initial & Last Name & Degree
Cornell Calinescu
Facility Name
Carteret Medical Group
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2524998623
First Name & Middle Initial & Last Name & Degree
Mary Katherine Lawrence
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Lillestol
Facility Name
CTI-CRC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
5135336325
First Name & Middle Initial & Last Name & Degree
James Paul Maynard
Facility Name
Office 18
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
412-650-6155
First Name & Middle Initial & Last Name & Degree
Bryce A. Palchick
Facility Name
Tribe Clinical Research, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
864-334-0141
First Name & Middle Initial & Last Name & Degree
Ronald Mayfield
Facility Name
Trial Management Associates
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donald Charles Eagerton
Facility Name
Tribe Clinical Research - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Michael Davis
Facility Name
FutureSearch Trials of Neurology
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Douglas Hudson
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
972-566-7799
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
801-409-2040
First Name & Middle Initial & Last Name & Degree
Michael D Woolman
Facility Name
Centro Médico Viamonte
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1120AAC
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Aizenberg
Facility Name
Consultorio de Investigación Clínica EMO SRL
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Rene Costanzo
Facility Name
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
City
Ciudad Autonoma de Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jimena Coronel
Facility Name
Centro de Salud e Investigaciones Médicas
City
Santa Rosa
State/Province
La Pampa
ZIP/Postal Code
6300
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Alejandro Mayer
Facility Name
The AIM Centre / Hunter Diabetes Centre
City
Merewether
State/Province
New South Wales
ZIP/Postal Code
2291
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61249632323
First Name & Middle Initial & Last Name & Degree
Claire Morbey
Facility Name
Woolcock Institute of Medical Research
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2037
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61298053248
First Name & Middle Initial & Last Name & Degree
Ron Grunstein
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61736468111
First Name & Middle Initial & Last Name & Degree
Donald Soutter Alexander McLeod
Facility Name
Core Research Group
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61738765688
First Name & Middle Initial & Last Name & Degree
David Martin Colquhoun
Facility Name
Nightingale Research
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hamilton
Facility Name
Southern Adelaide Diabetes & Endocrine Services
City
Oaklands Park
State/Province
South Australia
ZIP/Postal Code
5046
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
610874258690
First Name & Middle Initial & Last Name & Degree
Stephen Neil Stranks
Facility Name
Flinders University
City
Bedford Park
State/Province
South Aust
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61874219780
First Name & Middle Initial & Last Name & Degree
Danny J. Eckert
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Li Yee
Facility Name
Austin Health - Repatriation Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0394962160
First Name & Middle Initial & Last Name & Degree
Elif Ekinci
Facility Name
GenesisCare
City
Joondalup
State/Province
Western Australia
ZIP/Postal Code
6027
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61894006133
First Name & Middle Initial & Last Name & Degree
Peter Walter Purnell
Facility Name
The Second Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
15838123695
First Name & Middle Initial & Last Name & Degree
Qingju Li
Facility Name
Baotou Central Hospital
City
Bao Tou
State/Province
Inner Mongolia
ZIP/Postal Code
014040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhu
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
18951762690
First Name & Middle Initial & Last Name & Degree
Yibing Lu
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
15843081103
First Name & Middle Initial & Last Name & Degree
guixia wang
Facility Name
The First Affiliated Hospital of Xi'an Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710077
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya Li
Facility Name
Pudong New Area People's Hospital Shanghai
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201200
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaozhen JIANG
Facility Name
West China Hospital of Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
18980601658
First Name & Middle Initial & Last Name & Degree
zhenmei an
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
13780008400
First Name & Middle Initial & Last Name & Degree
Jialin Li
Facility Name
V.S. General Hospital
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DHAIWAT MRUGESH SHUKLA
Facility Name
Avron Hospitals
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380013
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiven Marwah
Facility Name
Zydus Hospitals & Healthcare Research Pvt.Ltd.
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitthaldas N Shah
Facility Name
Life Care Hospital and Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560092
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sreenivasa Murthy
Facility Name
Sushruta Multispeciality Hospital & Research Centre
City
Hubli
State/Province
Karnataka
ZIP/Postal Code
580021
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raghavendra Belgaonkar
Facility Name
CHL Hospital Indore
City
Indore
State/Province
Madhya Pradesh
ZIP/Postal Code
452008
Country
India
Individual Site Status
Recruiting
Facility Contact:
Phone
919977999687
First Name & Middle Initial & Last Name & Degree
Sandeep Julka
Facility Name
Sawai Man Singh Medical College Hospital (SMS Hospital)
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302004
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
09414048666
First Name & Middle Initial & Last Name & Degree
SANDEEP KUMAR MATHUR
Facility Name
Madras Diabetes Research Foundation
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600086
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VISWANATHAN MOHAN
Facility Name
Christian Medical College Vellore
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihal Thomas
Facility Name
Care Hospitals Hyderabad- Banjara Hills
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bipin Kumar Sethi
Facility Name
Kumudini Devi Diabetes Research Center
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500072
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
917842041355
First Name & Middle Initial & Last Name & Degree
Vishnupriya Rao Paturi
Facility Name
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700020
Country
India
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sujoy Ghosh
Facility Name
Korea University Ansan Hospital
City
Ansan-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
Phone
82314124274
First Name & Middle Initial & Last Name & Degree
NANHEE KIM
Facility Name
Hanyang University Guri Hospital
City
Guri-si
State/Province
Kyǒnggi-do
ZIP/Postal Code
11923
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Beom Lee
Facility Name
Yeungnam Univeristy Medical Center
City
Gyeongsan-si
State/Province
Kyǒngsangbuk-do
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Sung Moon
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Min Cho
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
State/Province
Seoul-teuk
ZIP/Postal Code
3722
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
82222281943
First Name & Middle Initial & Last Name & Degree
Yong-ho Lee
Facility Name
Ulsan University Hospital
City
Ulsan
State/Province
Ulsan-Kwangyǒkshi
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
01032352748
First Name & Middle Initial & Last Name & Degree
ILSEONG NAMGOONG
Facility Name
Centro de Investigacion en Artritis y Osteoporosis SC
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21200
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
6865534121
First Name & Middle Initial & Last Name & Degree
Francisco Javier Lopez Maldonado
Facility Name
RM Pharma Specialists
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525565501629
First Name & Middle Initial & Last Name & Degree
Mariana Zolandi Crespo
Facility Name
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11650
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
525585340943
First Name & Middle Initial & Last Name & Degree
Melchor Alpizar
Facility Name
Diseno y Planeacion en Investigacion Medica
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44130
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
5233305493
First Name & Middle Initial & Last Name & Degree
Cesar Gonzalo Calvo
Facility Name
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
5233361654104
First Name & Middle Initial & Last Name & Degree
Maria Del Rosario Arechavaleta Granell
Facility Name
Unidad de Investigación Clínica y Atención Médica HEPA
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
523336422886
First Name & Middle Initial & Last Name & Degree
Marisol Herrera Marmolejo
Facility Name
Cardiolink Clin Trials
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
8140401554
First Name & Middle Initial & Last Name & Degree
Elías García
Facility Name
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
City
Chihuahua
ZIP/Postal Code
31110
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
526144398618
First Name & Middle Initial & Last Name & Degree
Luis Alejandro Nevarez
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
522299327808
First Name & Middle Initial & Last Name & Degree
Alejandro Quintin Barrat Hernandez
Facility Name
Arké SMO S.A de C.V
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
2299314102
First Name & Middle Initial & Last Name & Degree
Luis Horacio Aguilar Espinoza
Facility Name
Diabdana
City
Oradea
State/Province
Bihor
ZIP/Postal Code
410147
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
004072248022
First Name & Middle Initial & Last Name & Degree
Dana Cosma
Facility Name
Geea Medical Easy Diet
City
Bucharest
State/Province
București
ZIP/Postal Code
010627
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40314288633
First Name & Middle Initial & Last Name & Degree
Georgeta Vacaru
Facility Name
Centrul Medical NutriLife
City
Bucharest
State/Province
București
ZIP/Postal Code
013761
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
0040212323445
First Name & Middle Initial & Last Name & Degree
Marlena Pascu
Facility Name
Gama Diamed
City
Mangalia
State/Province
Constanța
ZIP/Postal Code
905500
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
0040241740581
First Name & Middle Initial & Last Name & Degree
Amalia Drobeta Thury-Burileanu
Facility Name
Centrul Medical Mediab
City
Târgu-Mureș
State/Province
Mureș
ZIP/Postal Code
540142
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
400744572303
First Name & Middle Initial & Last Name & Degree
Carmen Crisan
Facility Name
CMI Dr.Pletea Noemi SRL
City
Bacău
ZIP/Postal Code
600154
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
Phone
40744775762
First Name & Middle Initial & Last Name & Degree
NOEMI NICOLETA PLETEA
Facility Name
Centro Periférico de Especialidades Bola Azul
City
Almeria
State/Province
Almería
ZIP/Postal Code
04009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034678510067
First Name & Middle Initial & Last Name & Degree
Pedro Mezquita-Raya
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
State/Province
Andalucía
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
951032000
First Name & Middle Initial & Last Name & Degree
Francisco Jose Tinahones Madueno
Facility Name
Complejo Asistencial Universitario de León - Hospital de León
City
León
State/Province
Castilla Y León
ZIP/Postal Code
24071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34987237400
First Name & Middle Initial & Last Name & Degree
Maria Dolores Ballesteros Pomar
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
0034913369082
First Name & Middle Initial & Last Name & Degree
Jose Maria Fernandez Rodriguez
Facility Name
Vithas Hospital Sevilla
City
Seville
State/Province
Sevilla
ZIP/Postal Code
41950
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
658011529
First Name & Middle Initial & Last Name & Degree
Cristobal Jesus Morales Portillo
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
955012000
First Name & Middle Initial & Last Name & Degree
Virginia Bellido
Facility Name
Chang Gung Memorial Hospital at Kaohsiung
City
Kaohsiung Niao Sung Dist
State/Province
Kaohsiung
ZIP/Postal Code
83301
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886975056106
First Name & Middle Initial & Last Name & Degree
Chih-Yuan Fang
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
State/Province
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886424739595
First Name & Middle Initial & Last Name & Degree
Chien-Ning Huang
Facility Name
Taipei Veterans General Hospital
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
886228712121
First Name & Middle Initial & Last Name & Degree
Chern-En Chiang

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
a are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/408215
Description
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight (TRIUMPH-2)

Learn more about this trial

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

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