ACTIVE_NOT_RECRUITING

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

Conditions

Obesity Glucagon-like peptide-1 (GLP-1)Leptin Incretin Weight maintenance

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-24

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06373146

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

STUDY_DIRECTOR

Eli Lilly and Company

Study Locations (Sites)

Velocity Clinical Research, Gardena

Gardena, California, 90247

United States

Irvine Clinical Research

Irvine, California, 92614

United States

Velocity Clinical Research, Westlake

Los Angeles, California, 90057

United States

Velocity Clinical Research, North Hollywood

North Hollywood, California, 91606

United States

Velocity Clinical Research, Santa Ana

Santa Ana, California, 92704

United States

Velocity Clinical Research, Panorama City

Van Nuys, California, 91405

United States

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598

United States

Solaris Clinical Research

Meridian, Idaho, 83646

United States

Tandem Clinical Research

Marrero, Louisiana, 70072

United States

Velocity Clinical Research - New Orleans

New Orleans, Louisiana, 70119

United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, 08053

United States

Lillestol Research

Fargo, North Dakota, 58104

United States

CTI Clinical Research Center

Cincinnati, Ohio, 45212

United States

South Texas Clinical Research

Corpus Christi, Texas, 78404

United States

Velocity Clinical Research, Dallas

Dallas, Texas, 75230

United States

Juno Research

Houston, Texas, 77040

United States

Northwest Clinical Research Center

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-24

Study Completion Date2026-04

Study Record Updates

Study Start Date2024-04-24

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Glucagon-like peptide-1 (GLP-1)
Leptin
Incretin
Weight maintenance

Additional Relevant MeSH Terms

Obesity