AzTrials
AzTrials

ObesityPhase 2NCT06901349

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

A Phase 2 study testing Bimagrumab and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 50 sites in 5 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight
What is being tested?
Bimagrumab and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
50 sitesin 5 countries
Study dates
23 May 2025to 10 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

50 sites in 5 countries.

50 sites in 5 countries

United States25 sites

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Bingham Memorial Hospital

    Blackfoot, Idaho, 83221

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Kur Research - Columbia Medical

    Columbia, Maryland, 21045

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Family First Medical Center

    Idaho Falls, Idaho, 83404

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Activian Clinical Research

    Kingwood, Texas, 77339

  • Orange County Research Center

    Lake Forest, California, 92630

  • Balanced Life Health Care Solutions/SKYCRNG

    Lawrenceville, Georgia, 30046

  • Healthy Brain Clinic

    Long Beach, California, 90804

  • L&C Professional Medical Research Institute

    Miami, Florida, 33144

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • Deaconess Clinic- Gateway

    Newburgh, Indiana, 47630

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Central States Research

    Tulsa, Oklahoma, 74136

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Yuma Clinical Trials

    Yuma, Arizona, 85364

Other trials in United States

Japan8 sites

  • Hayashi Diabetes Internal Medicine Clinic

    Chigasaki, Kanagawa, 253-0044

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Shonan Takai Clinic

    Kamakura, Kanagawa, 247-0055

  • Takai Internal Medicine Clinic

    Kamakura-shi, Kanagawa, 247-0056

  • Tokuyama Clinic

    Mihama-ku,Chiba City, Chiba, 261-0004

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

Other trials in Japan

Canada7 sites

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6

  • Premier Clinical Trial Network

    Hamilton, Ontario, L8L 5G4

  • Your Research Network

    Niagara Falls, Ontario, L2H 1H5

  • Centricity Research Pointe-Claire Multispecialty

    Pointe-Claire, Quebec, H9R 4S3

  • Diex Recherche Quebec

    Québec, G1V 4T3

  • Richmond Clinical Trials

    Richmond, British Columbia, V6V 2L1

  • Diex Recherche Trois-Rivieres

    Trois-Rivières, Quebec, G9A 4P3

Other trials in Canada

China6 sites

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, Henan, 471003

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

Other trials in China

Argentina4 sites

  • CIPREC

    Buenos Aires, Buenos Aires F.D., C1119ACN

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, Buenos Aires F.D., C1405BUB

  • CIPREC

    Buenos Aires, C1061AAS

Other trials in Argentina

About this study

Official title: 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.

Conditions
Obesity, Overweight
Being tested
Bimagrumab, Tirzepatide, Bimagrumab Placebo, Tirzepatide Placebo
Keywords
Type 2 Diabetes, Muscle, Lean, Fat
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2, Platelet Glycoprotein IV Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BimagrumabDrug

    Also called LY3985863

    Administered SC

  • TirzepatideDrug

    Also called LY3298176

    Administered SC

  • Bimagrumab PlaceboDrug

    Administered SC

  • Tirzepatide PlaceboDrug

    Administered SC

Study groups in NCT06901349
Study groupRoleWhat they receive
Bimagrumab Dose 1 + Tirzepatide PlaceboExperimentalParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide Placebo
Bimagrumab Dose 2 + Tirzepatide PlaceboExperimentalParticipants will receive bimagrumab SC and tirzepatide placebo SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide Placebo
Tirzepatide Dose 1 + Bimagrumab PlaceboExperimentalParticipants will receive tirzepatide SC and bimagrumab placebo SC
Receives: Drug: Tirzepatide; Drug: Bimagrumab Placebo
Tirzepatide Dose 2 + Bimagrumab PlaceboExperimentalParticipants will receive tirzepatide SC and bimagrumab placebo SC
Receives: Drug: Tirzepatide; Drug: Bimagrumab Placebo
Bimagrumab Dose 2 + Tirzepatide Dose 1ExperimentalParticipants will receive bimagrumab SC and tirzepatide SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide
Bimagrumab Dose 1 + Tirzepatide Dose 1ExperimentalParticipants will receive bimagrumab SC and tirzepatide SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide
Bimagrumab Dose 2 + Tirzepatide Dose 2ExperimentalParticipants will receive bimagrumab SC and tirzepatide SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide
Bimagrumab Dose 1 + Tirzepatide Dose 2ExperimentalParticipants will receive bimagrumab SC and tirzepatide SC
Receives: Drug: Bimagrumab; Drug: Tirzepatide
Bimagrumab Placebo + Tirzepatide PlaceboPlacebo comparatorParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC
Receives: Drug: Bimagrumab Placebo; Drug: Tirzepatide Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 36

Secondary outcomes (15)

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

    Measured: Baseline, Week 36

  2. Change from Baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline, Week 36

  3. Percentage of Participants Achieving ≥5% Body Weight Reduction

    Measured: Baseline, Week 36

  4. Percentage of Participants Achieving ≥10% Body Weight Reduction

    Measured: Baseline, Week 36

  5. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Measured: Baseline, Week 36

  6. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 36

  7. Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 36

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

    Measured: Baseline, Week 36

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

    Measured: Baseline, Week 36

  10. Change from Baseline in Liver Fat by MRI

    Measured: Baseline, Week 36

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

    Measured: Baseline, Week 36

  12. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 36

  13. Percent Change from Baseline in Triglycerides (TG)

    Measured: Baseline, Week 36

  14. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 36

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

    Measured: Predose through Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start23 May 2025
  3. Primary completion10 Jun 2025
  4. Study completion10 Jun 2025

Why it stopped: Study terminated for strategic business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06901349
Sponsor's protocol ID
27328
Other IDs
J4Z-MC-GIDI
Status last verified
Sep 2025
First submitted
24 Mar 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bimagrumab and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 50 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Japan, Canada, China, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight (time frame: Baseline, Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06901349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in