A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes

NCT07881458
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Not yet recruiting
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Participants
1,000
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Lead sponsor
Eli Lilly and Company
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Start date
2026-11-01
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Number of sites
75
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Summary
The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 2 years.
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Acronym
AMPLIFY-2
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Short title
A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes
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Official title
A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity or Overweight and Type 2 Diabetes
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-11-01
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First posted
2026-10-19
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Registry last updated
2026-10-19
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Primary completion date
2029-10-01
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Start date
2026-11-01
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Participants
1,000
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Participant count basis
Estimated
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Planned participants
1,000
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Protocol amendments
0
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Number of sites
75
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07881458
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ClinicalTrials.gov ID
NCT07881458
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 100

  1. Change from Baseline in Waist Circumference

    Timeframe: Baseline, Week 100

  2. Change from Baseline in Hemoglobin A1c (HbA1c)

    Timeframe: Baseline, Week 100

  3. Change from Baseline in Systolic Blood Pressure

    Timeframe: Baseline, Week 100

  4. Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Timeframe: Baseline, Week 100

  5. Percent Change from Baseline in Total Body Fat Mass

    Timeframe: Baseline, Week 100

  6. Change from Baseline in Body Mass Index (BMI)

    Timeframe: Baseline, Week 100

  7. Change from Baseline in Fasting Glucose

    Timeframe: Baseline, Week 100

  8. Percentage of Participants who Achieve a Composite of Body Weight Reduction ≥ 15% and HbA1c <6.5%

    Timeframe: Week 100

  9. Percent Change from Baseline in Total Cholesterol

    Timeframe: Baseline, Week 100

  10. Percent Change from Baseline in Fasting Insulin

    Timeframe: Baseline, Week 100

  11. Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

    Timeframe: Baseline, Week 100

  12. Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite CT) Total Score

    Timeframe: Baseline, Week 100

  13. Change from Baseline in EQ-5D-5L Score

    Timeframe: Baseline, Week 100

  14. Change from Baseline in Eating Behaviors and Attitudes Questionnaire (EBAQ) Score

    Timeframe: Baseline, Week 100

  15. Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight

    Timeframe: Baseline, Week 100

  16. Percentage of Participants with a Change in Medication Use

    Timeframe: Baseline, Week 100

  17. Overall Functional Assessment of Chronic Illness Therapy, Item GP5 (FACT-GP5) Score

    Timeframe: Week 100

  18. Pharmacokinetics (PK): Maximum Concentration of Eloralintide at Steady State (Cmax,ss)

    Timeframe: Baseline through Week 100

  19. PK: Area Under the Concentration Versus Time Curve of Eloralintide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

    Timeframe: Baseline through Week 100

  20. PK: Maximum Concentration of Tirzepatide at Steady State (Cmax,ss)

    Timeframe: Baseline through Week 100

  21. PK: Area Under the Concentration Versus Time Curve of Tirzepatide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

    Timeframe: Baseline through Week 100

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Have type 2 diabetes
  • Have a stable self-reported body weight (<5% body weight change) for 90 days prior to screening
  • Have a BMI of ≥27 kg/m2 at screening
  • Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight

  • Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)

  • Have a prior or planned endoscopic procedure and/or device-based therapy for obesity and/or type 2 diabetes (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)

  • Have type 1 diabetes

  • Have taken any of the following within 90 days prior to screening

    • medications with direct amylin, glucagon-like peptide-1 (GLP-1) or glucagon-dependent insulinotropic polypeptide (GIP) receptor activity, including compounded therapies
    • dipeptidyl peptidase 4 (DPP-4) inhibitors, and
    • insulin

  • Have had within 90 days prior to screening:

    • heart attack
    • stroke
    • coronary artery revascularization
    • unstable angina, or
    • hospitalization due to congestive heart failure

  • Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure

  • Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Sources for eligibility
clinicaltrials.gov

  • Tucson Clinical Research InstituteTucson, United States
  • Pacific Clinical Studies Inc.Los Alamitos, United States
  • Los Angeles Institute for Metabolic ResearchLos Angeles, United States
  • University of Colorado Anschutz Medical CampusAurora, United States
  • American Research Centers of FloridaPembroke Pines, United States
  • Encore Medical Research - WestonWeston, United States
  • Care Access - Dalton - Clinical Trials Center by Walmart & Care AccessDalton, United States
  • Pacific Diabetes & Endocrine CenterHonolulu, United States
  • DM Clinical Research - IndianapolisIndianapolis, United States
  • Care Access - EuniceEunice, United States
  • Tandem Clinical ResearchMarrero, United States
  • Care Access - St. LouisSt Louis, United States
  • IMA Clinical Research WarrenWarren Township, United States
  • NYC ResearchNew York, United States
  • IMA Clinical Research NYC MidtownNew York, United States
  • IMA Clinical Research AustinAustin, United States
  • Diabetes and Thyroid Center of Ft. WorthFort Worth, United States
  • Juno ResearchHouston, United States
  • Care Access - Houston - Clinical Trials Center by Walmart & Care AccessHouston, United States
  • ERA Health Research-TexasMidland, United States
  • Texas Valley Clinical Research (TVCR) - MissionMission, United States
  • IMA Clinical Research San AntonioSan Antonio, United States
  • Care Access - Tyler - Clinical Trials Center by Walmart & Care AccessTyler, United States
  • Washington Center for Weight Management and ResearchArlington, United States
  • Eastside Research AssociatesRedmond, United States

And 50 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2026-527230-31-00
  • J7C-MC-YQAB
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)