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

Purpose

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

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Part A: Bimagrumab Dose 2 + Tirzepatide Placebo	Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Placebo Administered SC
Active Comparator Part A: Bimagrumab Placebo + Tirzepatide Dose 1	Participants will receive bimagrumab placebo SC and tirzepatide SC	Drug: Tirzepatide Administered SC Other names: LY3298176 Drug: Bimagrumab Placebo Administered SC
Active Comparator Part A: Bimagrumab Placebo + Tirzepatide Dose 2	Participants will receive bimagrumab placebo SC and tirzepatide SC	Drug: Tirzepatide Administered SC Other names: LY3298176 Drug: Bimagrumab Placebo Administered SC
Experimental Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Placebo Comparator Part A: Bimagrumab Placebo + Tirzepatide Placebo	Participants will receive bimagrumab placebo SC and tirzepatide placebo SC	Drug: Bimagrumab Placebo Administered SC Drug: Tirzepatide Placebo Administered SC
Experimental Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1	Participants will receive bimagrumab SC and tirzepatide SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Part B: Bimagrumab Dose 1 + Tirzepatide Placebo	Participants will receive bimagrumab SC and tirzepatide placebo SC	Drug: Bimagrumab Administered SC Other names: LY3985863 BYM338 VER201 Drug: Tirzepatide Placebo Administered SC
Placebo Comparator Part B: Bimagrumab Placebo + Tirzepatide Placebo	Participants will receive bimagrumab placebo SC and tirzepatide placebo SC	Drug: Bimagrumab Placebo Administered SC Drug: Tirzepatide Placebo Administered SC

Recruiting Locations

Pinnacle Research Group, LLC
Anniston, Alabama 36207

Contact:
256-236-0055

Central Research Associates
Birmingham, Alabama 35205

Contact:
205-327-1077

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Contact:
925-930-7267

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida 32256

Contact:
904-281-5757

Altus Research
Lake Worth, Florida 33461

Contact:
561-641-0404

Suncoast Research Group
Miami, Florida 33135

Contact:
305-631-6704

East-West Medical Research Institute
Honolulu, Hawaii 96814

Contact:
808-531-6886

Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois 60640

Contact:
316-258-0060

SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157

Contact:
601-567-1321

Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462

Eastside Research Associates
Redmond, Washington 98052

Contact:
425-869-6828

Rainier Clinical Research Center
Renton, Washington 98057

Contact:
425-251-1720

More Details

NCT ID: NCT06643728
Status: Recruiting
Sponsor: Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
clinical_inquiry_hub@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.