A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Launched by ELI LILLY AND COMPANY · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LY3841136, both alone and with another medication called Tirzepatide, to help manage weight in adults who are overweight or have obesity and also have Type 2 diabetes. The goal is to see how safe and effective these treatments are over about 64 weeks. Participants should be between 18 and 75 years old, have a Body Mass Index (BMI) of 27 or higher, and have controlled their diabetes with diet, exercise, or certain medications for at least three months.

If you decide to participate, you can expect to be monitored closely throughout the study. However, there are some important criteria to keep in mind: you should not have any recent serious heart issues, certain kidney problems, or a history of severe low blood sugar. This trial is currently recruiting, so if you meet the eligibility requirements, you may have the opportunity to contribute to research that could improve weight management strategies for people with diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • W8M-MC-LAA2
• • Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
• • Have Type 2 Diabetes
• • Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening
• W8M-MC-CWMM:
• • Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)
• Exclusion Criteria:
• • W8M-MC-LAA2
• • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
• • Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
• • Have an elevated resting pulse rate (mean \>100 beats per minute (bpm)) or reduced resting pulse rate (mean \<60 bpm) at screening
• * Have any of the following cardiovascular conditions within 6 months prior to screening:
• • acute myocardial infarction
• • cerebrovascular accident (stroke)
• • unstable angina, or
• • hospitalization due to congestive heart failure
• • Have renal impairment measured as estimated glomerular filtration rate (eGFR) \<45 milliliters per minute (mL/min)/1.73 m2
• • Have a history of acute or chronic pancreatitis
• • Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
• • All concomitant medications should be at a stable dose for at least 3 months prior to screening
• • W8M-MC-CWMM
• • Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \>1 year prior to screening.
• • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
• • Have poorly controlled hypertension.
• • Have a history of symptomatic gallbladder disease within the past 2 years
• • Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
• • Have a lifetime history of suicide attempts.