A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

NCT06373146
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Completed
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Participants
392
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
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Start date
2024-04-24
clinicaltrials.gov
Number of sites
17
clinicaltrials.gov

Summary
The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.
clinicaltrials.gov
Short title
A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
clinicaltrials.gov
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of Once-Weekly Tirzepatide Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-04-02
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First posted
2024-04-18
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Registry last updated
2026-05-06
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Primary completion date
2025-12-15
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Start date
2024-04-24
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Actual participants
392
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Participants
392
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
17
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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
NCT06373146
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ClinicalTrials.gov ID
NCT06373146
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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. Mean Percent Change from Baseline in Body Weight

    Timeframe: Baseline, Week 48

  1. Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg)

    Timeframe: Baseline, Week 24

  2. Mean Absolute Change from Baseline for Body Weight (kg)

    Timeframe: Baseline, Week 48

  3. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Timeframe: Baseline to Week 48

  4. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Timeframe: Baseline to Week 48

  5. Percentage of Participants Who Achieve ≥15% Body Weight Reduction

    Timeframe: Baseline to Week 48

  6. Percentage of Participants Who Achieve ≥20 Body Weight Reduction

    Timeframe: Baseline to Week 48

  7. Mean Percent Change from Randomization 2 for Body Weight

    Timeframe: Week 24, Week 48

  8. Mean Change from Randomization 2 for Body Weight (kg)

    Timeframe: Week 24, Week 48

  9. Mean Absolute Change from Randomization 2 for Body Weight (kg)

    Timeframe: Week 24, Week 48

  10. Change from Baseline to Week 24 in CoEQ Scores

    Timeframe: Baseline, Week 24

  11. Change from Baseline to Week 48 in CoEQ Scores

    Timeframe: Baseline, Week 48

  12. Change from Baseline in FCQ-T-r Scores

    Timeframe: Baseline, Week 24

  13. Change from Baseline in FCQ-T-r Scores

    Timeframe: Baseline, Week 48

Sources for outcomes
clinicaltrials.gov

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

  • Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m²
  • Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention)
  • Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

  • Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change (increase or decrease) in body weight >5 kilogram (kg) within 3 months prior to screening
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2
  • Have acute or chronic hepatitis
  • Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Sources for eligibility
clinicaltrials.gov

  • Velocity Clinical Research, GardenaGardena, United States
  • Irvine Clinical ResearchIrvine, United States
  • Velocity Clinical Research, Los AngelesLos Angeles, United States
  • Velocity Clinical Research, North HollywoodNorth Hollywood, United States
  • Velocity Clinical Research, Santa AnaSanta Ana, United States
  • Velocity Clinical Research, Panorama CityVan Nuys, United States
  • Diablo Clinical Research, Inc.Walnut Creek, United States
  • Solaris Clinical ResearchMeridian, United States
  • Tandem Clinical ResearchMarrero, United States
  • Velocity Clinical Research - New OrleansNew Orleans, United States
  • Hassman Research Institute Marlton SiteMarlton, United States
  • Lillestol ResearchFargo, United States
  • CTI Clinical Research CenterCincinnati, United States
  • South Texas Clinical ResearchCorpus Christi, United States
  • Velocity Clinical Research, DallasDallas, United States
  • Juno ResearchHouston, United States
  • Northwest Clinical Research CenterBellevue, United States
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • I8F-MC-GPIV
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (3)