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

Eli Lilly and Company392 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

392

Conditions

Obesity

Interventions

TirzepatideDRUG

Administered SC

MibavademabDRUG

Administered SC

Tirzepatide-PlaceboDRUG

Administered SC

Mibavademab-Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Velocity Clinical Research, Gardena

Gardena, California, United States

Irvine Clinical Research

Irvine, California, United States

Outcomes

Primary Outcomes

Mean Percent Change from Baseline in Body Weight

Time frame: Baseline, Week 48

Secondary Outcomes

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

Time frame: Baseline, Week 24

Mean Absolute Change from Baseline for Body Weight (kg)

Time frame: Baseline, Week 48

Percentage of Participants Who Achieve ≥5% Body Weight Reduction

Time frame: Baseline to Week 48

Percentage of Participants Who Achieve ≥10% Body Weight Reduction

Time frame: Baseline to Week 48

Percentage of Participants Who Achieve ≥15% Body Weight Reduction

Time frame: Baseline to Week 48

Percentage of Participants Who Achieve ≥20 Body Weight Reduction

Time frame: Baseline to Week 48

Mean Percent Change from Randomization 2 for Body Weight

Time frame: Week 24, Week 48

Mean Change from Randomization 2 for Body Weight (kg)

Time frame: Week 24, Week 48

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

Time frame: Week 24, Week 48

Change from Baseline to Week 24 in CoEQ Scores

Time frame: Baseline, Week 24

Data from ClinicalTrials.gov

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