Obesity, Overweight
Conditions
Brief summary
The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.
Interventions
DRUGLY3305677
Administered SC. ISA specific interventions will be listed in the ISA.
DRUGLY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
DRUGTirzepatide
Administered SC. ISA specific interventions will be listed in the ISA.
DRUGLY3549492
Administered orally. ISA specific interventions will be listed in the ISA.
DRUGLY3532226
Administered SC. ISA specific interventions will be listed in the ISA.
DRUGPlacebo
Administered SC. ISA specific interventions will be listed in the ISA.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Have a body mass index (BMI) * ≥30 kilogram/square meter (kg/m²), or * ≥27 kg/m² and \<30 kg/m², or with at least 1 weight-related comorbidity * 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, 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: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure. * Have a history of symptomatic gallbladder disease within the past 2 years. * Have a lifetime history of suicide attempts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Allocated to Each ISA | Baseline to Week 6 | Each ISA will detail the intervention specific analysis. |
Countries
Argentina, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed