GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 2

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

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

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

252

actual

Study population

Obesity / overweight

Key I/E criterion

—

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 IDNCT06643728

Org study ID27265

Secondary IDJ4Z-MC-GIDFEli Lilly and Company

Timeline

Milestones

Study first posted2024-10-16actual

Study start2024-10-21actual

Primary completion2026-01-16actual

Last update posted2026-05-26actual

Study completion2027-01estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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)

Exclusion criteria

•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

Endpoints (11)

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.

Weight & body composition

11 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 24

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)