Bimagrumab and Tirzepatide for Weight Loss in Type 2 Diabetes
Bimagrumab
+ Tirzepatide
+ Tirzepatide Placebo
Body Weight+10
+ Diabetes Mellitus
+ Diabetes Mellitus, Type 2
Treatment Study
Summary
Study start date: May 23, 2025
Actual date on which the first participant was enrolled.This clinical trial aims to evaluate the effectiveness and safety of two medications, bimagrumab and tirzepatide, both individually and in combination, for people who are overweight or obese and also have type 2 diabetes. The study is important because managing body weight is a critical aspect of controlling type 2 diabetes, which can significantly impact a person's overall health and quality of life. By exploring these treatments, the study hopes to find better ways to help individuals reduce weight and improve their diabetes management. Participants in this study will be involved for approximately 13 months. During this time, they will receive either bimagrumab, tirzepatide, or a combination of both, or a placebo, which is a substance with no active medication. The treatments could be administered as injections or oral medications, depending on the drug's formulation. The study will monitor participants' body weight changes and assess any side effects to determine the safety and effectiveness of the treatments. This will help in understanding which treatment option might offer the best outcomes for weight reduction in individuals with type 2 diabetes.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion 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) Exclusion 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.9 intervention groups are designated in this study
11.111% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
ExperimentalGroup 5
ExperimentalGroup 6
ExperimentalGroup 7
ExperimentalGroup 8
ExperimentalGroup 9
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 50 locations
Yuma Clinical Trials
Yuma, United StatesOrange County Research Center
Lake Forest, United StatesHealthy Brain Clinic
Long Beach, United States