A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight
Recruiting · NCT06143956 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
56 locations listed across 22 US states.
- The Institute for Liver Health II dba Arizona Clinical Trials - Mesa - Chandler, Arizona, United States
- HOPE Research Institute - Phoenix, Arizona, United States
- Headlands Research - Scottsdale - Scottsdale, Arizona, United States
- The Institute for Liver Health II dba Arizona Liver Health-Tucson - Tucson, Arizona, United States
- NorCal Medical Research, Inc - Greenbrae, California, United States
- Velocity Clinical Research, Huntington Park - Huntington Park, California, United States
- Peninsula Research Associates - Rolling Hills Estates, California, United States
- Diablo Clinical Research, Inc. - Walnut Creek, California, United States
- Stamford Therapeutics Consortium - Stamford, Connecticut, United States
- Northeast Research Institute (NERI) - Fleming Island, Florida, United States
- New Horizon Research Center - Miami, Florida, United States
- Indago Research & Health Center, Inc - Miami Lakes, Florida, United States
- Suncoast Clinical Research, Inc. - New Port Richey, Florida, United States
- Charter Research - Winter Park - Orlando, Florida, United States
- Charter Research - Lady Lake - The Villages, Florida, United States
- Pacific Diabetes & Endocrine Center - Honolulu, Hawaii, United States
- Medical Research Partners - Ammon, Idaho, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- Great Lakes Clinical Trials - Ravenswood - Chicago, Illinois, United States
- NorthShore University Health System - Skokie, Illinois, United States
- Iowa Diabetes and Endocrinology Research Center - West Des Moines, Iowa, United States
- Cotton O'Neil Diabetes & Endocrinology - Topeka, Kansas, United States
- Monroe Biomedical Research - Louisville - Louisville, Kentucky, United States
- Knownwell - Needham, Massachusetts, United States
- Lucida Clinical Trials - New Bedford, Massachusetts, United States
- Headlands Research - Detroit - Southfield, Michigan, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division - Troy, Michigan, United States
- StudyMetrix Research - City of Saint Peters, Missouri, United States
- Clinvest Headlands Llc - Springfield, Missouri, United States
- Las Vegas Medical Research - Las Vegas, Nevada, United States
- Dent Neurologic Institute - Amherst, New York, United States
- Velocity Clinical Research, Syracuse - East Syracuse, New York, United States
- North Suffolk Neurology - Port Jefferson Station, New York, United States
- Rochester Clinical Research, LLC - Rochester, New York, United States
- Medication Management - Greensboro, North Carolina, United States
- Monroe Biomedical Research - Monroe, North Carolina, United States
- Lucas Research, Inc - Morehead City, North Carolina, United States
- Lucas Research, Inc. - New Bern, North Carolina, United States
- CTI Clinical Research Center - Cincinnati, Ohio, United States
- Tribe Clinical Research, LLC - Greenville, South Carolina, United States
- Quality Medical Research - Nashville, Tennessee, United States
- IMA Clinical Research Austin - Austin, Texas, United States
- Velocity Clinical Research, Dallas - Dallas, Texas, United States
- FutureSearch Trials of Dallas - Dallas, Texas, United States
- PlanIt Research, PLLC - Houston, Texas, United States
- Endeavor Clinical Trials - San Antonio, Texas, United States
- Tekton Research - Fredericksburg Road - San Antonio, Texas, United States
- Texas Valley Clinical Research - Weslaco, Texas, United States
- Sovah Clinical Research-River District - Danville, Virginia, United States
- Central Washington Health Services Association d/b/a Confluence Health - Wenatchee, Washington, United States
- Cicemo Srl - Buenos Aires, Argentina
- CARDIAMET Investigaciones Médicas - Buenos Aires, Argentina
- Centro de Investigaciones Metabólicas (CINME) - Buenos Aires, Argentina
- Centro Médico Viamonte - Buenos Aires, Argentina
- Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada - Buenos Aires, Argentina
- Instituto Médico Catamarca IMEC - Rosario, Argentina