A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

NCT06037252
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
414
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Lead sponsor
Eli Lilly and Company
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Start date
2023-09-21
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Number of sites
40
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Summary
The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.
clinicaltrials.gov
Short title
A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity
clinicaltrials.gov
Official title
A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-10-01
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First posted
2023-09-14
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Registry last updated
2026-03-23
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Primary completion date
2026-01-08
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Start date
2023-09-21
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Actual participants
414
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Participants
414
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
40
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Data monitoring committee
No
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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
NCT06037252
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ClinicalTrials.gov ID
NCT06037252
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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 0), Week 44

  1. Change from Baseline in HbA1c

    Timeframe: Baseline (Week 0), Week 44

  2. Change from Baseline in HbA1c

    Timeframe: Baseline (Week 24), Week 80

  3. Percent Change from Baseline in Body Weight

    Timeframe: Baseline (Week 24), Week 80

  4. Absolute Change from Baseline in Body Weight

    Timeframe: Baseline (Week 0), Week 44

  5. Absolute Change from Baseline in Body Weight

    Timeframe: Baseline (Week 24), Week 80

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

    Timeframe: Baseline (Week 0), Week 44

  7. Change from Baseline in BMI

    Timeframe: Baseline (Week 24), Week 80

  8. Change from Baseline in Waist Circumference

    Timeframe: Baseline (Week 0), Week 44

  9. Change from Baseline in Waist Circumference

    Timeframe: Baseline (Week 24), Week 80

  10. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Timeframe: Baseline (Week 0), Week 44

  11. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Timeframe: Baseline (Week 0), Week 80

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

    Timeframe: Baseline through Week 44

    Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.

Sources for outcomes
clinicaltrials.gov

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

  • Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
  • Have had stable body weight (±5%) during the 90 days preceding screening.
  • Have been diagnosed with Type 2 Diabetes (T2D).
  • Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.

  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.

  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

  • Have a prior or planned surgical treatment for obesity.

  • Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.

  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².

  • Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.

    • acute myocardial infarction.
    • cerebrovascular accident (stroke).
    • unstable angina .
    • hospitalization due to congestive heart failure, or
    • coronary artery revascularization.

  • Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2.

  • Have a history of chronic or acute pancreatitis.

Sources for eligibility
clinicaltrials.gov

  • Medical Advancement Centers of ArizonaPhoenix, United States
  • John Muir Physician Network Research CenterConcord, United States
  • Care Access - SacramentoSacramento, United States
  • Care Access - AuroraAurora, United States
  • Chase Medical Research, LLCWaterbury, United States
  • Retreat Medical ResearchMiami, United States
  • American Research Centers of FloridaPembroke Pines, United States
  • Alta Pharmaceutical Research CenterNorcross, United States
  • AGILE Clinical Research Trials, LLCSandy Springs, United States
  • Northwestern UniversityChicago, United States
  • Qualmedica Research, LLCEvansville, United States
  • Integrated Clinical Trial Services, Inc.West Des Moines, United States
  • Accellacare - Wilmington - 1917 Tradd CourtWilmington, United States
  • Velocity Clinical Research, Mt. AuburnCincinnati, United States
  • Summit HeadlandsPortland, United States
  • Clinical Research Associates IncNashville, United States
  • Juno ResearchHouston, United States
  • Southern Endocrinology AssociatesMesquite, United States
  • Charlottesville Medical ResearchCharlottesville, United States
  • Northwest Clinical Research CenterBellevue, United States
  • CEDICCABA, Argentina
  • Consultorio de Investigación Clínica EMO SRLCiudad Autonoma de Buenos Aires, Argentina
  • Centro Médico ViamonteBuenos Aires, Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica AplicadaBuenos Aires, Argentina
  • Centro de Investigaciones Metabólicas (CINME)Buenos Aires, Argentina

And 15 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • 2023-504561-24-00
  • I8F-MC-GPIT
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (6)

Targets (2)