NCT06643728

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 obesity

Timeline
8mo left

Started Oct 2024

Typical duration for phase_2 obesity

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Oct 2024Jan 2027

First Submitted

Initial submission to the registry

October 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 16, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.4 years

First QC Date

October 14, 2024

Last Update Submit

September 25, 2025

Conditions

ObesityOverweight

Keywords

MuscleLeanFat

Outcome Measures

Primary Outcomes (1)

  • Percent Change from Baseline in Body Weight

    Baseline, Week 24

Secondary Outcomes (10)

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

    Baseline, Week 24, Week 48

  • Change from Baseline in Body Weight

    Baseline, Week 24, Week 48

  • Percentage of Participants Achieving ≥5% Body Weight Reduction

    Baseline, Week 24, Week 48

  • Percentage of Participants Achieving ≥10% Body Weight Reduction

    Baseline, Week 24, Week 48

  • Percentage of Participants Achieving ≥15% Body Weight Reduction

    Baseline, Week 24, Week 48

  • +5 more secondary outcomes

Study Arms (12)

Part A: Bimagrumab Dose 2 + Tirzepatide Placebo

EXPERIMENTAL

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

Drug: BimagrumabDrug: Tirzepatide Placebo

Part A: Bimagrumab Placebo + Tirzepatide Dose 1

ACTIVE COMPARATOR

Participants will receive bimagrumab placebo SC and tirzepatide SC

Drug: TirzepatideDrug: Bimagrumab Placebo

Part A: Bimagrumab Placebo + Tirzepatide Dose 2

ACTIVE COMPARATOR

Participants will receive bimagrumab placebo SC and tirzepatide SC

Drug: TirzepatideDrug: Bimagrumab Placebo

Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part A: Bimagrumab Placebo + Tirzepatide Placebo

PLACEBO COMPARATOR

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Drug: Bimagrumab PlaceboDrug: Tirzepatide Placebo

Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide SC

Drug: BimagrumabDrug: Tirzepatide

Part B: Bimagrumab Dose 1 + Tirzepatide Placebo

EXPERIMENTAL

Participants will receive bimagrumab SC and tirzepatide placebo SC

Drug: BimagrumabDrug: Tirzepatide Placebo

Part B: Bimagrumab Placebo + Tirzepatide Placebo

PLACEBO COMPARATOR

Participants will receive bimagrumab placebo SC and tirzepatide placebo SC

Drug: Bimagrumab PlaceboDrug: Tirzepatide Placebo

Interventions

BimagrumabDRUG

Administered SC

Also known as: LY3985863, BYM338, VER201
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2Part A: Bimagrumab Dose 2 + Tirzepatide PlaceboPart B: Bimagrumab Dose 1 + Tirzepatide PlaceboPart B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
TirzepatideDRUG

Administered SC

Also known as: LY3298176
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2Part A: Bimagrumab Placebo + Tirzepatide Dose 1Part A: Bimagrumab Placebo + Tirzepatide Dose 2Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
Bimagrumab PlaceboDRUG

Administered SC

Part A: Bimagrumab Placebo + Tirzepatide Dose 1Part A: Bimagrumab Placebo + Tirzepatide Dose 2Part A: Bimagrumab Placebo + Tirzepatide PlaceboPart B: Bimagrumab Placebo + Tirzepatide Placebo
Tirzepatide PlaceboDRUG

Administered SC

Part A: Bimagrumab Dose 2 + Tirzepatide PlaceboPart A: Bimagrumab Placebo + Tirzepatide PlaceboPart B: Bimagrumab Dose 1 + Tirzepatide PlaceboPart B: Bimagrumab Placebo + Tirzepatide Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pinnacle Research Group, LLC

Anniston, Alabama, 36207, United States

Location

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Altus Research

Lake Worth, Florida, 33461, United States

Location

Suncoast Research Group

Miami, Florida, 33135, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, 60640, United States

Location

SKY Integrative Medical Center/SKYCRNG

Ridgeland, Mississippi, 39157, United States

Location

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Eastside Research Associates

Redmond, Washington, 98052, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Related Links

MeSH Terms

Conditions

ObesityOverweightPlatelet Glycoprotein IV Deficiency

Interventions

bimagrumabTirzepatide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2024

First Posted

October 16, 2024

Study Start

October 21, 2024

Primary Completion

April 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

US(12)