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WithdrawnPhase 2

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

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

50

Recruiting sites

Enrollment

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

BMI ≥27

Primary endpoint

Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06901349
Org study ID27328
Secondary IDJ4Z-MC-GIDIEli Lilly and Company

Timeline

Milestones

Study first posted2025-03-28actual
Study start2025-05-23actual
Primary completion2025-06-10actual
Study completion2025-06-10actual
Last update posted2025-09-24actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
9
Cardiometabolic biomarkers
4
Glycemic / diabetes
1
MASH / liver
1
Safety / tolerability / PK
1

Weight & body composition

9 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 36

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)

Time frame:Baseline, Week 36

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥5% Body Weight Reduction

Time frame:Baseline, Week 36

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥10% Body Weight Reduction

Time frame:Baseline, Week 36

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥15% Body Weight Reduction

Time frame:Baseline, Week 36

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 36

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 36

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist-to-Height Ratio (WHtR)

Time frame:Baseline, Week 36

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)

Time frame:Baseline, Week 36

Visceral fat, change

percent change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 36

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Liver Fat by MRI

Time frame:Baseline, Week 36

Liver fat content, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 36

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent Change from Baseline in Total Cholesterol

Time frame:Baseline, Week 36

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides (TG)

Time frame:Baseline, Week 36

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 36

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab

Time frame:Predose through Week 52

AUC₀–∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.