NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Obesity Overweight
Date of first enrollment	16/05/2025
Target sample size	180
Countries of recruitment	United States,Japan,Argentina,Japan,Canada,Japan,China,Japan
Study type	Interventional
Intervention(s)	DRUG: Bimagrumab(Other Name: LY3985863) Administered SC DRUG: Tirzepatide(Other Name: LY3298176) Administered SC DRUG: Bimagrumab Placebo Administered SC DRUG: Tirzepatide Placebo Administered SC (Study Arms) Experimental: Bimagrumab Dose 1 + Tirzepatide Placebo Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Placebo Experimental: Bimagrumab Dose 2 + Tirzepatide Placebo Participants will receive bimagrumab SC and tirzepatide placebo SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Placebo Experimental: Tirzepatide Dose 1 + Bimagrumab Placebo Participants will receive tirzepatide SC and bimagrumab placebo SC Interventions: Drug: Tirzepatide Drug: Bimagrumab Placebo Experimental: Tirzepatide Dose 2 + Bimagrumab Placebo Participants will receive tirzepatide SC and bimagrumab placebo SC Interventions: Drug: Tirzepatide Drug: Bimagrumab Placebo Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 1 Participants will receive bimagrumab SC and tirzepatide SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 1 Participants will receive bimagrumab SC and tirzepatide SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Experimental: Bimagrumab Dose 2 + Tirzepatide Dose 2 Participants will receive bimagrumab SC and tirzepatide SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Experimental: Bimagrumab Dose 1 + Tirzepatide Dose 2 Participants will receive bimagrumab SC and tirzepatide SC Interventions: Drug: Bimagrumab Drug: Tirzepatide Placebo Comparator: Bimagrumab Placebo + Tirzepatide Placebo Participants will receive bimagrumab placebo SC and tirzepatide placebo SC Interventions: Drug: Bimagrumab Placebo Drug: Tirzepatide Placebo

Outcome(s)

Primary Outcome	Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 36
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 75age old
Gender	Both
Include criteria	-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)
Exclude criteria	-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