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CompletedPhase 2

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

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

17

Recruiting sites

Enrollment

392

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06373146
Org study ID18750
Secondary IDI8F-MC-GPIVEli Lilly and Company

Timeline

Milestones

Study first posted2024-04-18actual
Study start2024-04-24actual
Primary completion2025-12-15actual
Study completion2026-04-02actual
Last update posted2026-05-06actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
10
Patient-reported / QoL
4

Weight & body composition

10 endpoints
Primary/protocol endpoint

Mean Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Absolute Change from Baseline for Body Weight (kg)

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame:Baseline to Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame:Baseline to Week 48

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame:Baseline to Week 48

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve ≥20 Body Weight Reduction

Time frame:Baseline to Week 48

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Mean Percent Change from Randomization 2 for Body Weight

Time frame:Week 24, Week 48

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Change from Randomization 2 for Body Weight (kg)

Time frame:Week 24, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 24, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Patient-reported / QoL

4 endpoints
Secondary/protocol endpoint

Change from Baseline to Week 24 in CoEQ Scores

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline to Week 48 in CoEQ Scores

Time frame:Baseline, Week 48

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in FCQ-T-r Scores

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in FCQ-T-r Scores

Time frame:Baseline, Week 48

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.