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OpenTrials
Completed

NCT Number: NCT06373146

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Velocity Clinical Research, Gardena, Gardena, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Mibavademab

Drug

Administered SC

Other names: REGN4461

Tirzepatide-Placebo

Drug

Administered SC

Mibavademab-Placebo

Drug

Administered SC

Primary outcomes

  1. Mean Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 48

Secondary outcomes

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 48

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

    Time frame: Baseline to Week 48

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

    Time frame: Baseline to Week 48

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

    Time frame: Baseline to Week 48

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

    Time frame: Baseline to Week 48

  7. Mean Percent Change from Randomization 2 for Body Weight

    Time frame: Week 24, Week 48

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

    Time frame: Week 24, Week 48

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

    Time frame: Week 24, Week 48

  10. Change from Baseline to Week 24 in CoEQ Scores

    Time frame: Baseline, Week 24

  11. Change from Baseline to Week 48 in CoEQ Scores

    Time frame: Baseline, Week 48

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

    Time frame: Baseline, Week 24

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

    Time frame: Baseline, Week 48

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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