ACTIVE_NOT_RECRUITING

A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight

Conditions

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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 evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight Without Type 2 Diabetes

Quick Facts

Study Start:2024-10-21

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06643728

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 to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have a BMI of * ≥30 kilograms per square meter (kg/m2) or * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities: * Hypertension * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)	* Have a prior or planned surgical treatment for obesity * Have at least one laboratory value suggestive of diabetes during screening * Use of metformin, or any other glucose-lowering medications * Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma * Have poorly controlled hypertension * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes * Have ongoing or a history of bradyarrhythmias other than sinus bradycardia * Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure * Have a history of symptomatic gallbladder disease within the past 2 years * Have signs and symptoms of any liver disease * Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality * Have a history of acute or chronic pancreatitis * Have renal impairment, measured as estimated glomerular filtration rate \<30 mL/minute/1.73 m2 * Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

Inclusion Criteria

Exclusion Criteria

* Have a BMI of
* ≥30 kilograms per square meter (kg/m2) or
* ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities:
* Hypertension
* Dyslipidemia
* Cardiovascular disease
* Obstructive sleep apnea
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

* Have a prior or planned surgical treatment for obesity
* Have at least one laboratory value suggestive of diabetes during screening
* Use of metformin, or any other glucose-lowering medications
* Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma
* Have poorly controlled hypertension
* Have any of the following cardiovascular conditions within 3 months prior to screening:
* acute myocardial infarction
* cerebrovascular accident (stroke)
* unstable angina, or
* hospitalization due to congestive heart failure
* Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
* Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
* Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
* Have a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease
* Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
* Have a history of acute or chronic pancreatitis
* Have renal impairment, measured as estimated glomerular filtration rate \<30 mL/minute/1.73 m2
* Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

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)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207

United States

Central Research Associates

Birmingham, Alabama, 35205

United States

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598

United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256

United States

Altus Research

Lake Worth, Florida, 33461

United States

Suncoast Research Group

Miami, Florida, 33135

United States

East-West Medical Research Institute

Honolulu, Hawaii, 96814

United States

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640

United States

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157

United States

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, 19462

United States

Eastside Research Associates

Redmond, Washington, 98052

United States

Rainier Clinical Research Center

Renton, Washington, 98057

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 Date2024-10-21

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-10-21

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Muscle
Lean
Fat

Additional Relevant MeSH Terms

Obesity
Overweight