ObesityPhase 2NCT06643728
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 study testing Bimagrumab and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 12 sites in United States.
Trial 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. 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
- 252 participants
- Where
- 12 sitesUnited States
- Study dates
- 21 Oct 2024to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 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)
Who cannot join
- 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:
Show all 19Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Central Research Associates
Birmingham, Alabama, 35205
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640
East-West Medical Research Institute
Honolulu, Hawaii, 96814
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256
Altus Research
Lake Worth, Florida, 33461
Suncoast Research Group
Miami, Florida, 33135
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania, 19462
Eastside Research Associates
Redmond, Washington, 98052
Rainier Clinical Research Center
Renton, Washington, 98057
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, 39157
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
About this study
Official title: 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
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.
- Conditions
- Obesity, Overweight
- Being tested
- Bimagrumab, Tirzepatide, Bimagrumab Placebo, Tirzepatide Placebo
- Keywords
- Muscle, Lean, Fat
- Medical subject headings
- Obesity, Overweight, 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, BYM338, VER201
Administered SC
TirzepatideDrug
Also called LY3298176
Administered SC
Bimagrumab PlaceboDrug
Administered SC
Tirzepatide PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A: Bimagrumab Dose 2 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Receives: Drug: Bimagrumab; Drug: Tirzepatide Placebo |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 1 | Active comparator | Participants will receive bimagrumab placebo SC and tirzepatide SC Receives: Drug: Tirzepatide; Drug: Bimagrumab Placebo |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 2 | Active comparator | Participants will receive bimagrumab placebo SC and tirzepatide SC Receives: Drug: Tirzepatide; Drug: Bimagrumab Placebo |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part A: Bimagrumab Placebo + Tirzepatide Placebo | Placebo comparator | Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Receives: Drug: Bimagrumab Placebo; Drug: Tirzepatide Placebo |
| Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 | Experimental | Participants will receive bimagrumab SC and tirzepatide SC Receives: Drug: Bimagrumab; Drug: Tirzepatide |
| Part B: Bimagrumab Dose 1 + Tirzepatide Placebo | Experimental | Participants will receive bimagrumab SC and tirzepatide placebo SC Receives: Drug: Bimagrumab; Drug: Tirzepatide Placebo |
| Part B: Bimagrumab Placebo + Tirzepatide Placebo | Placebo comparator | Participants 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.
Percent Change from Baseline in Body Weight
Measured: Baseline, Week 24
Secondary outcomes (10)
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Measured: Baseline, Week 24, Week 48
Change from Baseline in Body Weight
Measured: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥5% Body Weight Reduction
Measured: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥10% Body Weight Reduction
Measured: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥15% Body Weight Reduction
Measured: Baseline, Week 24, Week 48
Change from Baseline in Waist Circumference
Measured: Baseline, Week 24, Week 48
Change from Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 24, Week 48
Change from Baseline in Waist-to-Height Ratio (WHtR)
Measured: Baseline, Week 24, Week 48
Percent Change from Baseline in Visceral Adipose Tissue (VAT)
Measured: Baseline, Week 24, Week 48
Percent Change from Baseline in Total Body Lean Mass by DXA
Measured: Baseline, Week 24, Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start21 Oct 2024
- Primary completion16 Jan 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643728
- Sponsor's protocol ID
- 27265
- Other IDs
- J4Z-MC-GIDF
- Status last verified
- May 2026
- First submitted
- 14 Oct 2024
- Last updated
- 26 May 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06643728
- Acronym / sponsor ID
- 27265
- Conditions
- Obesity, Overweight
- Keywords
- Muscle, Lean, Fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A: Bimagrumab Dose 2 + Tirzepatide Placebo | Experimental | Drug: Bimagrumab, Drug: Tirzepatide PlaceboParticipants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 1 | Active comparator | Drug: Tirzepatide, Drug: Bimagrumab PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide SC |
| Part A: Bimagrumab Placebo + Tirzepatide Dose 2 | Active comparator | Drug: Tirzepatide, Drug: Bimagrumab PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide SC |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part A: Bimagrumab Placebo + Tirzepatide Placebo | Placebo comparator | Drug: Bimagrumab Placebo, Drug: Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC |
| Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 | Experimental | Drug: Bimagrumab, Drug: TirzepatideParticipants will receive bimagrumab SC and tirzepatide SC |
| Part B: Bimagrumab Dose 1 + Tirzepatide Placebo | Experimental | Drug: Bimagrumab, Drug: Tirzepatide PlaceboParticipants will receive bimagrumab SC and tirzepatide placebo SC |
| Part B: Bimagrumab Placebo + Tirzepatide Placebo | Placebo comparator | Drug: Bimagrumab Placebo, Drug: Tirzepatide PlaceboParticipants will receive bimagrumab placebo SC and tirzepatide placebo SC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have a BMI of
- Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BimagrumabAlso: LY3985863, BYM338, VER201Administered SC | Drug | Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1, Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2, Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2, Part A: Bimagrumab Dose 2 + Tirzepatide Placebo, Part B: Bimagrumab Dose 1 + Tirzepatide Placebo, Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1, Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1, Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 |
| TirzepatideAlso: LY3298176Administered SC | Drug | Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1, Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2, Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2, Part A: Bimagrumab Placebo + Tirzepatide Dose 1, Part A: Bimagrumab Placebo + Tirzepatide Dose 2, Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1, Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1, Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1 |
| Bimagrumab PlaceboAdministered SC | Drug | Part A: Bimagrumab Placebo + Tirzepatide Dose 1, Part A: Bimagrumab Placebo + Tirzepatide Dose 2, Part A: Bimagrumab Placebo + Tirzepatide Placebo, Part B: Bimagrumab Placebo + Tirzepatide Placebo |
| Tirzepatide PlaceboAdministered SC | Drug | Part A: Bimagrumab Dose 2 + Tirzepatide Placebo, Part A: Bimagrumab Placebo + Tirzepatide Placebo, Part B: Bimagrumab Dose 1 + Tirzepatide Placebo, Part B: Bimagrumab Placebo + Tirzepatide Placebo |
Primary outcome
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 24
10 secondary outcomes
Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Body Weight
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥5% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥10% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Percentage of Participants Achieving ≥15% Body Weight Reduction
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 24, Week 48
Change from Baseline in Waist-to-Height Ratio (WHtR)
Time frame: Baseline, Week 24, Week 48
Percent Change from Baseline in Visceral Adipose Tissue (VAT)
Time frame: Baseline, Week 24, Week 48
Percent Change from Baseline in Total Body Lean Mass by DXA
Time frame: Baseline, Week 24, Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or OverweightLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
12 sites in 1 country: see every site and its status.
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 12 sites in United States.
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 8 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 May 2026.