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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Anniston

Pinnacle Research Group, LLC, Anniston, Alabama, United States, 36207

Birmingham

Central Research Associates, Birmingham, Alabama, United States, 35205

Walnut Creek

Diablo Clinical Research, Inc., Walnut Creek, California, United States, 94598

Jacksonville

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

Lake Worth

Altus Research, Lake Worth, Florida, United States, 33461

Miami

Suncoast Research Group, Miami, Florida, United States, 33135

Honolulu

East-West Medical Research Institute, Honolulu, Hawaii, United States, 96814

Chicago

Great Lakes Clinical Trials - Ravenswood, Chicago, Illinois, United States, 60640

Ridgeland

SKY Integrative Medical Center/SKYCRNG, Ridgeland, Mississippi, United States, 39157

Plymouth Meeting

Keystone Clinical Studies, Plymouth Meeting, Pennsylvania, United States, 19462

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

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

Study Record Dates

2027-01