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

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ClinicalTrials.gov Identifier: NCT05929079
Recruitment Status : Recruiting
First Posted : July 3, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Overweight Obstructive Sleep Apnea Drug: Retatrutide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : July 11, 2023
Estimated Primary Completion Date : May 3, 2026
Estimated Study Completion Date : May 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Retatrutide Dose 1
Participants will receive retatrutide subcutaneously (SC).
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Experimental: Retatrutide Dose 2
Participants will receive retatrutide SC.
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Experimental: Retatrutide Dose 3
Participants will receive retatrutide SC.
 Drug: Retatrutide
Administered SC
Other Name: LY3437943
Placebo Comparator: Placebo
Participants will receive placebo.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 80 ]
  2. Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset [ Time Frame: Baseline, Week 80 ]

Secondary Outcome Measures :
  1. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 80 ]
  2. Change from Baseline in Waist Circumference [ Time Frame: Baseline, Week 80 ]
  3. Change from Baseline in Systolic Blood Pressure (SBP) [ Time Frame: Baseline, Week 80 ]
  4. Change from Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: Baseline, Week 80 ]
  5. Percent Change from Baseline in Total Cholesterol [ Time Frame: Baseline, Week 80 ]
  6. Percent Change from Baseline in Triglycerides [ Time Frame: Baseline, Week 80 ]
  7. Change from Baseline in Hemoglobin (A1c) HbA1c % [ Time Frame: Baseline, Week 80 ]
  8. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [ Time Frame: Baseline, Week 80 ]
  9. Change from Baseline in Fasting Glucose [ Time Frame: Baseline, Week 80 ]
  10. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) [ Time Frame: Baseline through Week 80 ]
    AUC is presented as a single average measure of AUC across the study duration.

  11. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset [ Time Frame: Baseline, Week 80 ]
  12. 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 [ Time Frame: Baseline to Week 80 ]
    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.

  13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset [ Time Frame: Baseline to Week 80 ]
  14. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset [ Time Frame: Week 80 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05929079


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05929079    
Other Study ID Numbers: 18558
J1I-MC-GZBK ( Other Identifier: Master Protocol Eli Lilly and Company )
J1I-MC-GSA2 ( Other Identifier: ISA Eli Lilly and Company )
2023-503658-11-00 ( Other Identifier: EU Trial Number )
First Posted: July 3, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 1, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Body Weight
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases