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

A Phase 2b 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 With Type 2 Diabetes

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.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Tirzepatide; Drug: Bimagrumab; Drug: Tirzepatide Placebo; Drug: Bimagrumab Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1061AAS
    • CIPREC
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
      • Centro Medico Viamonte
    • Buenos Aires, Buenos Aires F.D., Argentina, C1405BUB
      • Consultorio de Investigacion Clinica EMO SRL
    • Buenos Aires, Buenos Aires F.D., Argentina, C1119ACN
      • CIPREC
• Canada
  • Québec, Canada, G1V 4T3
    • Diex Recherche Québec
  • British Columbia
    • Richmond, British Columbia, Canada, V6V 2L1
      • Richmond Clinical Trials
  • Ontario
    • Brampton, Ontario, Canada, L6S 0C6
      • Centricity Research Brampton Endocrinology
    • Hamilton, Ontario, Canada, L8L 5G4
      • Premier Clinical Trial Network
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Your Research Network
  • Quebec
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Centricity Research Pointe-Claire Multispecialty
    • Trois-Rivières, Quebec, Canada, G9A 4P3
      • Diex Recherche Trois-Rivieres
• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • The Fourth Affiliated Hospital of Harbin Medical University
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China, 215006
      • the First Affiliated Hospital of Soochow University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Sixth People's Hospital
• Japan
  • Chiba
    • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
      • Tokuyama Clinic
  • Kanagawa
    • Chigasaki, Kanagawa, Japan, 253-0044
      • Hayashi Diabetes Internal Medicine Clinic
    • Kamakura, Kanagawa, Japan, 247-0055
      • Shonan Takai Clinic
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Takai Internal Medicine Clinic
  • Osaka
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0002
      • The Institute of Medical Science, Asahi Life Foundation
• United States
  • Arizona
    • Yuma, Arizona, United States, 85364
      • Yuma Clinical Trials
  • California
    • Lake Forest, California, United States, 92630
      • Orange County Research Center
    • Long Beach, California, United States, 90804
      • Healthy Brain Clinic
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    • Miami, Florida, United States, 33144
      • L&C Professional Medical Research Institute
    • Miami Lakes, Florida, United States, 33016
      • Global Health Research Center, Inc.
    • Orlando, Florida, United States, 32803
      • Charter Research - Winter Park
    • The Villages, Florida, United States, 32162
      • Charter Research - Lady Lake
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Balanced Life Health Care Solutions/SKYCRNG
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East-West Medical Research Institute
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Bingham Memorial Hospital
    • Idaho Falls, Idaho, United States, 83404
      • Family First Medical Center
  • Indiana
    • Newburgh, Indiana, United States, 47630
      • Deaconess Clinic- Gateway
  • Maryland
    • Columbia, Maryland, United States, 21045
      • Kur Research - Columbia Medical
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc.
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • Central States Research
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research, Dallas
    • Houston, Texas, United States, 77079
      • PlanIt Research, PLLC
    • Kingwood, Texas, United States, 77339
      • Activian Clinical Research
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bimagrumab Dose 1 + Tirzepatide Placebo; Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC	Drug: Bimagrumab; Administered SC; Other Names: LY3985863; Drug: Tirzepatide Placebo; Administered SC
Experimental: Bimagrumab Dose 2 + Tirzepatide Placebo; Participants will receive bimagrumab SC and tirzepatide placebo SC	Drug: Bimagrumab; Administered SC; Other Names: LY3985863; Drug: Tirzepatide Placebo; Administered SC
Experimental: Tirzepatide Dose 1 + Bimagrumab Placebo; Participants will receive tirzepatide SC and bimagrumab placebo SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab Placebo; Administered SC
Experimental: Tirzepatide Dose 2 + Bimagrumab Placebo; Participants will receive tirzepatide SC and bimagrumab placebo SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab Placebo; Administered SC
Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 1; Participants will receive bimagrumab SC and tirzepatide SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab; Administered SC; Other Names: LY3985863
Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 1; Participants will receive bimagrumab SC and tirzepatide SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab; Administered SC; Other Names: LY3985863
Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 2; Participants will receive bimagrumab SC and tirzepatide SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab; Administered SC; Other Names: LY3985863
Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 2; Participants will receive bimagrumab SC and tirzepatide SC	Drug: Tirzepatide; Administered SC; Other Names: LY3298176; Drug: Bimagrumab; Administered SC; Other Names: LY3985863
Placebo Comparator: Bimagrumab Placebo + Tirzepatide Placebo; Participants will receive bimagrumab placebo SC and tirzepatide placebo SC	Drug: Tirzepatide Placebo; Administered SC; Drug: Bimagrumab Placebo; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent Change from Baseline in Body Weight	Baseline, Week 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 36
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)	Baseline, Week 36
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 36
Percentage of Participants Achieving ≥5% Body Weight Reduction	Baseline, Week 36
Percentage of Participants Achieving ≥10% Body Weight Reduction	Baseline, Week 36
Percentage of Participants Achieving ≥15% Body Weight Reduction	Baseline, Week 36
Change from Baseline in Waist Circumference	Baseline, Week 36
Change from Baseline in Waist-to-Height Ratio (WHtR)	Baseline, Week 36
Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)	Baseline, Week 36
Change from Baseline in Liver Fat by MRI	Baseline, Week 36
Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Baseline, Week 36
Percent Change from Baseline in Total Cholesterol	Baseline, Week 36
Percent Change from Baseline in Triglycerides (TG)	Baseline, Week 36
Change from Baseline in Systolic Blood Pressure (SBP)	Baseline, Week 36
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab	Predose through Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Actual): June 10, 2025
• Study Completion (Actual): June 10, 2025

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Fat; Muscle; Lean
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Diabetes Mellitus, Type 2; Platelet Glycoprotein IV Deficiency; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide; bimagrumab
• Other Study ID Numbers: 27328; J4Z-MC-GIDI (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No