A Study of Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Participants With Obesity or Overweight With Type 2 Diabetes
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT06901349
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
- 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)
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bimagrumab Dose 1 + Tirzepatide Placebo Bimagrumab Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Bimagrumab Dose 1 + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Bimagrumab Dose 2 + Tirzepatide Placebo Bimagrumab Participants will receive bimagrumab SC and tirzepatide placebo SC Bimagrumab Dose 2 + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab SC and tirzepatide placebo SC Tirzepatide Dose 1 + Bimagrumab Placebo Tirzepatide Participants will receive tirzepatide SC and bimagrumab placebo SC Tirzepatide Dose 1 + Bimagrumab Placebo Bimagrumab Placebo Participants will receive tirzepatide SC and bimagrumab placebo SC Tirzepatide Dose 2 + Bimagrumab Placebo Tirzepatide Participants will receive tirzepatide SC and bimagrumab placebo SC Tirzepatide Dose 2 + Bimagrumab Placebo Bimagrumab Placebo Participants will receive tirzepatide SC and bimagrumab placebo SC Bimagrumab Dose 2 + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 2 + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 1 + Tirzepatide Dose 1 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 1 + Tirzepatide Dose 1 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 2 + Tirzepatide Dose 2 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 2 + Tirzepatide Dose 2 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 1 + Tirzepatide Dose 2 Bimagrumab Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Dose 1 + Tirzepatide Dose 2 Tirzepatide Participants will receive bimagrumab SC and tirzepatide SC Bimagrumab Placebo + Tirzepatide Placebo Bimagrumab Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Bimagrumab Placebo + Tirzepatide Placebo Tirzepatide Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 36
- Secondary Outcome Measures
Name Time Method Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA) Baseline, Week 36 Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 36 Percentage of Participants Achieving ≥5% Body Weight Reduction Baseline, Week 36 Percentage of Participants Achieving ≥10% Body Weight Reduction Baseline, Week 36 Percentage of Participants Achieving ≥15% Body Weight Reduction Baseline, Week 36 Change from Baseline in Waist Circumference Baseline, Week 36 Change from Baseline in Body Mass Index (BMI) Baseline, Week 36 Change from Baseline in Waist-to-Height Ratio (WHtR) Baseline, Week 36 Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI) Baseline, Week 36 Change from Baseline in Liver Fat by MRI Baseline, Week 36 Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP) Baseline, Week 36 Percent Change from Baseline in Total Cholesterol Baseline, Week 36 Percent Change from Baseline in Triglycerides (TG) Baseline, Week 36 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 36 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab Predose through Week 52
Related Research Topics
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Trial Locations
- Locations (48)
Yuma Clinical Trials
🇺🇸Yuma, Arizona, United States
Orange County Research Center
🇺🇸Lake Forest, California, United States
Healthy Brain Clinic
🇺🇸Long Beach, California, United States
Valley Clinical Trials, Inc.
🇺🇸Northridge, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Jacksonville, Florida, United States
Global Health Research Center, Inc.
🇺🇸Miami Lakes, Florida, United States
L&C Professional Medical Research Institute
🇺🇸Miami, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Family First Medical Center
🇺🇸Idaho Falls, Idaho, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Balanced Life Health Care Solutions/SKYCRNG
🇺🇸Lawrenceville, Georgia, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Bingham Memorial Hospital
🇺🇸Blackfoot, Idaho, United States
Deaconess Clinic- Gateway
🇺🇸Newburgh, Indiana, United States
Kur Research - Columbia Medical
🇺🇸Columbia, Maryland, United States
Remington-Davis, Inc
🇺🇸Columbus, Ohio, United States
Central States Research
🇺🇸Tulsa, Oklahoma, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Activian Clinical Research
🇺🇸Kingwood, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
CIPREC
🇦🇷Buenos Aires, Argentina
Centro Médico Viamonte
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Consultorio de Investigación Clínica EMO SRL
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centricity Research Brampton Endocrinology
🇨🇦Brampton, Ontario, Canada
Premier Clinical Trial Network
🇨🇦Hamilton, Ontario, Canada
Your Research Network
🇨🇦Niagara Falls, Ontario, Canada
Centricity Research Pointe-Claire Multispecialty
🇨🇦Pointe-Claire, Quebec, Canada
Diex Recherche Trois-Rivieres
🇨🇦Trois-Rivieres, Quebec, Canada
Diex Recherche Quebec
🇨🇦Quebec, Canada
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Takai Internal Medicine Clinic
🇯🇵Kamakura-shi, Kanagawa, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
The Institute of Medical Science, Asahi Life Foundation
🇯🇵Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Tokuyama Clinic
🇯🇵Mihama-ku,Chiba City, Chiba, Japan
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Hayashi Diabetes Internal Medicine Clinic
🇯🇵Chigasaki, Kanagawa, Japan
Shonan Takai Clinic
🇯🇵Kamakura, Kanagawa, Japan
Fukuwa Clinic
🇯🇵Chuo-ku, Tokyo, Japan