Peninsula Research Associates, Inc. | Rolling Hills Estates, CA
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About
The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3305677 compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.
Enrollment
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Inclusion criteria
W8M-MC-OXA1:
W8M-MC-CWMM:
Have a BMI ≥27 kilograms per square meter (kg/m²) with at least one of the following weight-related comorbidities:
Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss).
Exclusion criteria
W8M-MC-OXA1:
Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.
Have any of the following cardiovascular conditions within 6 months prior to screening:
Have a history of acute or chronic pancreatitis.
Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.
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 signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
Have any of the following cardiovascular conditions within 3 months prior to Screening:
Have a history of symptomatic gallbladder disease within the past 2 years.
Have a lifetime history of suicide attempts.
Primary purpose
Allocation
Interventional model
Masking
165 participants in 4 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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