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

What Was Tested

The trial (phase 2) is built around Tirzepatide.

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.

It had eight arms (groups): Tirzepatide (TZP) + Mibavademab (MIBA) [Group A] (experimental), TZP + Mibavademab-placebo (MIBA-PBO) [Group B] (experimental), TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C] (experimental), TZP + MIBA [Group D] (experimental) and TZP + MIBA-PBO [Group E] (experimental).

Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24.

Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24.

Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

392 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m². Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: 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 family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2; have acute or chronic hepatitis.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

The Tirzepatide group and the comparison group ran side by side rather than switching.

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-24 with completion listed for 2025-12-15.

It ran at 17 sites in United States (17).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mean Percent Change from Baseline in Body Weight (time frame: Baseline, Week 48).

It also tracked 13 secondary outcomes, for example Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg), Mean Absolute Change from Baseline for Body Weight (kg), Mean Percent Change from Randomization 2 for Body Weight, Mean Change from Randomization 2 for Body Weight (kg), Mean Absolute Change from Randomization 2 for Body Weight (kg) and Change from Baseline to Week 24 in CoEQ Scores.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 392 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.