Clinical trial

A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

Recruiting now · Phase 2 · 2 countries · Registry ID NCT06143956

Recruiting nowPhase 2Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

LY3305677

Drug

Administered SC. ISA specific interventions will be listed in the ISA.

LY3841136

Drug

Administered SC. ISA specific interventions will be listed in the ISA.

Tirzepatide

Drug

Administered SC. ISA specific interventions will be listed in the ISA.

LY3549492

Drug

Administered orally. ISA specific interventions will be listed in the ISA.

LY3532226

Drug

Administered SC. ISA specific interventions will be listed in the ISA.

Placebo

Drug

Administered SC. ISA specific interventions will be listed in the ISA.

Placebo

Drug

Administered orally. ISA specific interventions will be listed in the ISA.

Primary outcomes

Number of Participants Allocated to Each ISABaseline to Week 6

Each ISA will detail the intervention specific analysis.

Study locations

56 locations were listed when this page was built. The first 40 are shown.

CARDIAMET Investigaciones Médicas🇦🇷 Buenos Aires, Argentina
Study contactContact
Angela Romero ZarantePrincipal Investigator
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada🇦🇷 Buenos Aires, Argentina
Study contactContact
Evelyn BlancPrincipal Investigator
Centro Médico Viamonte🇦🇷 Buenos Aires, Argentina
Study contactContact
Diego AizenbergPrincipal Investigator
Centro de Investigaciones Metabólicas (CINME)🇦🇷 Buenos Aires, Argentina
Study contactContact
Federico Perez ManghiPrincipal Investigator
Cicemo Srl🇦🇷 Buenos Aires, Argentina
Study contactContact
Pablo CostanzoPrincipal Investigator
Instituto Médico Catamarca IMEC🇦🇷 Rosario, Argentina
Study contactContact
Natacha MaldonadoPrincipal Investigator
Dent Neurologic Institute🇺🇸 Amherst, New York, United States
Laszlo MechtlerPrincipal Investigator
Medical Research Partners🇺🇸 Ammon, Idaho, United States
Study contactContact
Joseph MoorePrincipal Investigator
IMA Clinical Research Austin🇺🇸 Austin, Texas, United States
Study contactContact
Nomita KimPrincipal Investigator
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa🇺🇸 Chandler, Arizona, United States
Yessica SachdevaPrincipal Investigator
Great Lakes Clinical Trials - Ravenswood🇺🇸 Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood🇺🇸 Chicago, Illinois, United States
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Rupal TrivediPrincipal Investigator
CTI Clinical Research Center🇺🇸 Cincinnati, Ohio, United States
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James MaynardPrincipal Investigator
StudyMetrix Research🇺🇸 City of Saint Peters, Missouri, United States
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Timothy SmithPrincipal Investigator
FutureSearch Trials of Dallas🇺🇸 Dallas, Texas, United States
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Michael DowningPrincipal Investigator
Velocity Clinical Research, Dallas🇺🇸 Dallas, Texas, United States
Dan LenderPrincipal Investigator
Sovah Clinical Research-River District🇺🇸 Danville, Virginia, United States
Study contactContact
Stephan JannachPrincipal Investigator
Velocity Clinical Research, Syracuse🇺🇸 East Syracuse, New York, United States
Rachel DubroffPrincipal Investigator
Northeast Research Institute (NERI)🇺🇸 Fleming Island, Florida, United States
NorCal Medical Research, Inc🇺🇸 Greenbrae, California, United States
Study contactContact
Linda GaudianiPrincipal Investigator
Medication Management🇺🇸 Greensboro, North Carolina, United States
Study contactContact
James FranklinPrincipal Investigator
Tribe Clinical Research, LLC🇺🇸 Greenville, South Carolina, United States
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Ronald MayfieldPrincipal Investigator
Pacific Diabetes & Endocrine Center🇺🇸 Honolulu, Hawaii, United States
PlanIt Research, PLLC🇺🇸 Houston, Texas, United States
Study contactContact
Amer Al-KaradshehPrincipal Investigator
Velocity Clinical Research, Huntington Park🇺🇸 Huntington Park, California, United States
Study contactContact
Stanley HsiaPrincipal Investigator
Las Vegas Medical Research🇺🇸 Las Vegas, Nevada, United States
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Cornell CalinescuPrincipal Investigator
Monroe Biomedical Research - Louisville🇺🇸 Louisville, Kentucky, United States
Study contactContact
Harold BaysPrincipal Investigator
New Horizon Research Center🇺🇸 Miami, Florida, United States
Study contactContact
Lazaro NunezPrincipal Investigator
Indago Research & Health Center, Inc🇺🇸 Miami Lakes, Florida, United States
Study contactContact
Jose CardonaPrincipal Investigator
Monroe Biomedical Research🇺🇸 Monroe, North Carolina, United States
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Awawu IgbinadolorPrincipal Investigator
Lucas Research, Inc🇺🇸 Morehead City, North Carolina, United States
Study contactContact
Kathryn LucasPrincipal Investigator
Quality Medical Research🇺🇸 Nashville, Tennessee, United States
Study contactContact
Saras SharmaPrincipal Investigator
Knownwell🇺🇸 Needham, Massachusetts, United States
Study contactContact
Angela FitchPrincipal Investigator
Lucida Clinical Trials🇺🇸 New Bedford, Massachusetts, United States
Study contactContact
David ShihPrincipal Investigator
Lucas Research, Inc.🇺🇸 New Bern, North Carolina, United States
Study contactContact
Joseph MaidesPrincipal Investigator
Suncoast Clinical Research, Inc.🇺🇸 New Port Richey, Florida, United States
Study contactContact
Cathy BarnesPrincipal Investigator
Charter Research - Winter Park🇺🇸 Orlando, Florida, United States
Study contactContact
Edgardo Rivera-RiveraPrincipal Investigator
HOPE Research Institute🇺🇸 Phoenix, Arizona, United States
North Suffolk Neurology🇺🇸 Port Jefferson Station, New York, United States
Rochester Clinical Research, LLC🇺🇸 Rochester, New York, United States
Study contactContact
Patrick ConnorsPrincipal Investigator