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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05929079




Registration number
NCT05929079
Ethics application status
Date submitted
26/06/2023
Date registered
3/07/2023

Titles & IDs
Public title
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Scientific 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
Secondary ID [1] 0 0
J1I-MC-GZBK
Secondary ID [2] 0 0
18558
Universal Trial Number (UTN)
Trial acronym
TRIUMPH-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 0 0
Obesity 0 0
Overweight 0 0
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Metabolic and Endocrine 0 0 0 0
Diabetes
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Retatrutide
Treatment: Drugs - Placebo

Experimental: Retatrutide Dose 1 - Participants will receive retatrutide subcutaneously (SC).

Experimental: Retatrutide Dose 2 - Participants will receive retatrutide SC.

Experimental: Retatrutide Dose 3 - Participants will receive retatrutide SC.

Placebo comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: Retatrutide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change from Baseline in Body Weight
Timepoint [1] 0 0
Baseline, Week 80
Primary outcome [2] 0 0
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [1] 0 0
Change from Baseline in Body Mass Index (BMI)
Timepoint [1] 0 0
Baseline, Week 80
Secondary outcome [2] 0 0
Change from Baseline in Waist Circumference
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [3] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [3] 0 0
Baseline, Week 80
Secondary outcome [4] 0 0
Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [4] 0 0
Baseline, Week 80
Secondary outcome [5] 0 0
Percent Change from Baseline in Total Cholesterol
Timepoint [5] 0 0
Baseline, Week 80
Secondary outcome [6] 0 0
Percent Change from Baseline in Triglycerides
Timepoint [6] 0 0
Baseline, Week 80
Secondary outcome [7] 0 0
Change from Baseline in Hemoglobin (A1c) HbA1c %
Timepoint [7] 0 0
Baseline, Week 80
Secondary outcome [8] 0 0
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Timepoint [8] 0 0
Baseline, Week 80
Secondary outcome [9] 0 0
Change from Baseline in Fasting Glucose
Timepoint [9] 0 0
Baseline, Week 80
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Timepoint [10] 0 0
Baseline through Week 80
Secondary outcome [11] 0 0
Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Timepoint [11] 0 0
Baseline, Week 80
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Baseline to Week 80
Secondary outcome [13] 0 0
Percentage of Participants with =50% AHI Reduction from Baseline for GSA2 Subset
Timepoint [13] 0 0
Baseline to Week 80
Secondary outcome [14] 0 0
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10 for GSA2 Subset
Timepoint [14] 0 0
Week 80

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Macquarie Park
Recruitment hospital [2] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Core Research Group - Brisbane
Recruitment hospital [5] 0 0
Nightingale Research - Adelaide
Recruitment hospital [6] 0 0
Flinders University - Bedford Park
Recruitment hospital [7] 0 0
Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
Recruitment hospital [8] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [9] 0 0
Emeritus Research - Camberwell
Recruitment hospital [10] 0 0
Austin Health - Repatriation Hospital - Heidelberg West
Recruitment hospital [11] 0 0
Advara HeartCare Joondalup - Joondalup
Recruitment postcode(s) [1] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [2] 0 0
2291 - Merewether
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4064 - Brisbane
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3124 - Camberwell
Recruitment postcode(s) [10] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [11] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Argentina
State/province [21] 0 0
Ciudad Autónoma De Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
La Pampa
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Paulo
Country [24] 0 0
Brazil
State/province [24] 0 0
São Paulo
Country [25] 0 0
India
State/province [25] 0 0
Chhattisgarh
Country [26] 0 0
India
State/province [26] 0 0
Gujarat
Country [27] 0 0
India
State/province [27] 0 0
Karnataka
Country [28] 0 0
India
State/province [28] 0 0
Madhya Pradesh
Country [29] 0 0
India
State/province [29] 0 0
New South Wales
Country [30] 0 0
India
State/province [30] 0 0
Tamil Nadu
Country [31] 0 0
India
State/province [31] 0 0
Telangana
Country [32] 0 0
India
State/province [32] 0 0
West Bengal
Country [33] 0 0
Mexico
State/province [33] 0 0
Baja California
Country [34] 0 0
Mexico
State/province [34] 0 0
Distrito Federal
Country [35] 0 0
Mexico
State/province [35] 0 0
Jalisco
Country [36] 0 0
Mexico
State/province [36] 0 0
Morelos
Country [37] 0 0
Mexico
State/province [37] 0 0
Nuevo León
Country [38] 0 0
Mexico
State/province [38] 0 0
Yucatán
Country [39] 0 0
Mexico
State/province [39] 0 0
Chihuahua
Country [40] 0 0
Mexico
State/province [40] 0 0
Veracruz
Country [41] 0 0
Romania
State/province [41] 0 0
Bihor
Country [42] 0 0
Romania
State/province [42] 0 0
Bucure?ti
Country [43] 0 0
Romania
State/province [43] 0 0
Constan?a
Country [44] 0 0
Romania
State/province [44] 0 0
Mure?
Country [45] 0 0
Romania
State/province [45] 0 0
Bacau
Country [46] 0 0
Spain
State/province [46] 0 0
Almería
Country [47] 0 0
Spain
State/province [47] 0 0
Andalucía
Country [48] 0 0
Spain
State/province [48] 0 0
Castilla Y León
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid, Comunidad De
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05929079