A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes

NCT ID: NCT06901349

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2025-06-10

Brief Summary

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The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bimagrumab Dose 1 + Tirzepatide Placebo

Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide Placebo

Intervention Type DRUG

Administered SC

Bimagrumab Dose 2 + Tirzepatide Placebo

Participants will receive bimagrumab SC and tirzepatide placebo SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide Placebo

Intervention Type DRUG

Administered SC

Tirzepatide Dose 1 + Bimagrumab Placebo

Participants will receive tirzepatide SC and bimagrumab placebo SC

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Placebo

Intervention Type DRUG

Administered SC

Tirzepatide Dose 2 + Bimagrumab Placebo

Participants will receive tirzepatide SC and bimagrumab placebo SC

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Placebo

Intervention Type DRUG

Administered SC

Bimagrumab Dose 2 + Tirzepatide Dose 1

Participants will receive bimagrumab SC and tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Dose 1 + Tirzepatide Dose 1

Participants will receive bimagrumab SC and tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Dose 2 + Tirzepatide Dose 2

Participants will receive bimagrumab SC and tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Dose 1 + Tirzepatide Dose 2

Participants will receive bimagrumab SC and tirzepatide SC

Group Type EXPERIMENTAL

Bimagrumab

Intervention Type DRUG

Administered SC

Tirzepatide

Intervention Type DRUG

Administered SC

Bimagrumab Placebo + Tirzepatide Placebo

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Group Type PLACEBO_COMPARATOR

Bimagrumab Placebo

Intervention Type DRUG

Administered SC

Tirzepatide Placebo

Intervention Type DRUG

Administered SC

Interventions

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Bimagrumab

Administered SC

Intervention Type DRUG

Tirzepatide

Administered SC

Intervention Type DRUG

Bimagrumab Placebo

Administered SC

Intervention Type DRUG

Tirzepatide Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3985863 LY3298176

Eligibility Criteria

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Inclusion Criteria

* Have type 2 diabetes
* Have a BMI of ≥27 kilograms per square meter (kg/m2)
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria

* Have a prior or planned surgical treatment for obesity,
* Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or 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 a history of New York Heart Association (NYHA) Functional Classification III or IV 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 renal impairment
* 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
* Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Yuma Clinical Trials

Yuma, Arizona, United States

Site Status

Orange County Research Center

Lake Forest, California, United States

Site Status

Healthy Brain Clinic

Long Beach, California, United States

Site Status

Valley Clinical Trials, Inc.

Northridge, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States

Site Status

L&C Professional Medical Research Institute

Miami, Florida, United States

Site Status

Global Health Research Center, Inc.

Miami Lakes, Florida, United States

Site Status

Charter Research - Winter Park

Orlando, Florida, United States

Site Status

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status

Balanced Life Health Care Solutions/SKYCRNG

Lawrenceville, Georgia, United States

Site Status

East-West Medical Research Institute

Honolulu, Hawaii, United States

Site Status

Bingham Memorial Hospital

Blackfoot, Idaho, United States

Site Status

Family First Medical Center

Idaho Falls, Idaho, United States

Site Status

Deaconess Clinic- Gateway

Newburgh, Indiana, United States

Site Status

Kur Research - Columbia Medical

Columbia, Maryland, United States

Site Status

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status

University of North Carolina Medical Center

Chapel Hill, North Carolina, United States

Site Status

Remington-Davis, Inc

Columbus, Ohio, United States

Site Status

Central States Research

Tulsa, Oklahoma, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

PlanIt Research, PLLC

Houston, Texas, United States

Site Status

Activian Clinical Research

Kingwood, Texas, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

CIPREC

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Centro Médico Viamonte

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Consultorio de Investigación Clínica EMO SRL

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

CIPREC

Buenos Aires, , Argentina

Site Status

Richmond Clinical Trials

Richmond, British Columbia, Canada

Site Status

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Site Status

Premier Clinical Trial Network

Hamilton, Ontario, Canada

Site Status

Your Research Network

Niagara Falls, Ontario, Canada

Site Status

Centricity Research Pointe-Claire Multispecialty

Pointe-Claire, Quebec, Canada

Site Status

Diex Recherche Trois-Rivieres

Trois-Rivières, Quebec, Canada

Site Status

Diex Recherche Quebec

Québec, , Canada

Site Status

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, China

Site Status

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Jinan Central Hospital

Jinan, Shandong, China

Site Status

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, Japan

Site Status

Hayashi Diabetes Internal Medicine Clinic

Chigasaki, Kanagawa, Japan

Site Status

Shonan Takai Clinic

Kamakura, Kanagawa, Japan

Site Status

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, Japan

Site Status

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

Site Status

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, Japan

Site Status

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, Japan

Site Status

Fukuwa Clinic

Chuo-ku, Tokyo, Japan

Site Status

Countries

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United States Argentina Canada China Japan

Related Links

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https://trials.lilly.com/en-US/trial/587595

A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants with Obesity or Overweight with Type 2 Diabetes

Other Identifiers

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J4Z-MC-GIDI

Identifier Type: OTHER

Identifier Source: secondary_id

27328

Identifier Type: -

Identifier Source: org_study_id

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