Suspended

Bimagrumab and Tirzepatide for Weight Loss in Type 2 Diabetes

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Bimagrumab

+ Tirzepatide

+ Tirzepatide Placebo

Drug
Who is being recruted

Body Weight+10

+ Diabetes Mellitus

+ Diabetes Mellitus, Type 2

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 23, 2025

Actual date on which the first participant was enrolled.

This clinical trial aims to evaluate the effectiveness and safety of two medications, bimagrumab and tirzepatide, both individually and in combination, for people who are overweight or obese and also have type 2 diabetes. The study is important because managing body weight is a critical aspect of controlling type 2 diabetes, which can significantly impact a person's overall health and quality of life. By exploring these treatments, the study hopes to find better ways to help individuals reduce weight and improve their diabetes management. Participants in this study will be involved for approximately 13 months. During this time, they will receive either bimagrumab, tirzepatide, or a combination of both, or a placebo, which is a substance with no active medication. The treatments could be administered as injections or oral medications, depending on the drug's formulation. The study will monitor participants' body weight changes and assess any side effects to determine the safety and effectiveness of the treatments. This will help in understanding which treatment option might offer the best outcomes for weight reduction in individuals with type 2 diabetes.

Official TitleA 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
NCT06901349
Principal SponsorEli Lilly and Company
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

9 intervention groups are designated in this study

11.111% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants will receive bimagrumab SC and tirzepatide SC

Group II

Experimental
Participants will receive bimagrumab SC and tirzepatide SC

Group III

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

Group IV

Experimental
Participants will receive bimagrumab SC and tirzepatide SC

Group 5

Experimental
Participants will receive bimagrumab SC and tirzepatide SC

Group 6

Experimental
Participants will receive bimagrumab SC and tirzepatide placebo SC

Group 7

Experimental
Participants will receive tirzepatide SC and bimagrumab placebo SC

Group 8

Experimental
Participants will receive tirzepatide SC and bimagrumab placebo SC

Group 9

Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 50 locations

Suspended

Fukuwa Clinic

Chuo-ku, JapanOpen Fukuwa Clinic in Google Maps
Suspended

Yuma Clinical Trials

Yuma, United States
Suspended

Orange County Research Center

Lake Forest, United States
Suspended

Healthy Brain Clinic

Long Beach, United States
Suspended50 Study Centers