Clinical trial NCT06972459: A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
Official title: A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-05-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3b
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO.

Participation in the study will last about 18 months.


Eligibility criteria: Inclusion Criteria:

* Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:

  * hypertension
  * dyslipidemia
  * obstructive sleep apnea, or
  * cardiovascular disease
* Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
* Have an unstable body weight within 90 days prior to screening
* Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
* Have acute or chronic hepatitis or pancreatitis
* Are taking other medications or alternative remedies to manage weight loss

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Percent Change from Baseline in Body Weight at Week 72
timeFrame: Baseline, Week 72
measure: Percentage of Participants Achieving Weight Reduction of ≥5%
timeFrame: Baseline up to 72 weeks
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline up to 72 weeks
measure: Change from Baseline in Body Max Index (BMI)
timeFrame: Baseline, Week 72
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline up to 72 weeks
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline up to 72 weeks
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline up to 72 weeks
measure: Change from Baseline in EQ-5D-5L
timeFrame: Baseline, Week 72
measure: Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron
timeFrame: Predose through Week 48
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novak Clinical Research - Tucson - North La Cholla Boulevard
state: Arizona
city: San Ramon
country: United States
facility: Norcal Endocrinology & Internal Medicine
state: California
city: Santa Ana
country: United States
facility: Southern California Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Care Access - Thousand Oaks
state: California
city: DeLand
country: United States
facility: Accel Research Sites - DeLand Clinical Research Unit
state: Florida
city: Fort Lauderdale
country: United States
facility: Innovation Medical Research Center - Fort Lauderdale
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology P.A.
state: Florida
city: Tampa
country: United States
facility: Care Access - Tampa
state: Florida
city: Decatur
country: United States
facility: Care Access - Decatur
state: Georgia
city: Decatur
country: United States
facility: Accel Research Sites - NeuroStudies Clinical Research Unit
state: Georgia
city: Savannah
country: United States
facility: Javara - Privia Medical Group Georgia - Savannah
state: Georgia
city: Woodstock
country: United States
facility: North Georgia Clinical Research
state: Georgia
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: New Iberia
country: United States
facility: Care Access - New Iberia
state: Louisiana
city: Rockville
country: United States
facility: Endocrine and Metabolic Consultants
state: Maryland
city: Silver Spring
country: United States
facility: Javara - Privia Medical Group - Silver Spring
state: Maryland
city: Missoula
country: United States
facility: Boeson Research MSO
state: Montana
city: Carson City
country: United States
facility: Javara - Nevada Health Centers - Carson City
state: Nevada
city: Las Vegas
country: United States
facility: The Machuca Foundation
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Javara - Tryon Medical Partners
state: North Carolina
city: Fayetteville
country: United States
facility: Care Access - Fayetteville
state: North Carolina
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Mission
country: United States
facility: Texas Valley Clinical Research (TVCR) - Mission
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CARE - Centro de Alergia y Enfermedades Respiratorias
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma de Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Ciudad Autónoma de Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: Santa Fe
country: Argentina
facility: Centro de Diagnóstico y Rehabilitación (CEDIR)
city: Hefei
country: China
facility: The Second People's Hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
state: Tianjin
city: Ceske Budejovice
country: Czechia
facility: MUDr. Alena Vachova
state: Jihočeský kraj
city: Ostrava
country: Czechia
facility: VASOMED Clinic
state: Moravskoslezský kraj
city: Praha
country: Czechia
facility: Milan Kvapil s.r.o., Diabetologicka ambulance
state: Praha 4
city: Uherske Hradiste
country: Czechia
facility: Medical Plus
state: Zlínský kraj
city: Český Krumlov
country: Czechia
facility: Nemocnice Cesky Krumlov
city: Munich
country: Germany
facility: Medicover Neuroendokrinologie
state: Bayern
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: AmBeNet GmbH
state: Sachsen
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wilhelmsburg
city: Guwahati
country: India
facility: Apollo Excelcare Hospital
state: Assam
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Hubli
country: India
facility: Karnataka Institute of Medical Sciences
state: Karnataka
city: Pune
country: India
facility: Chellaram Diabetes Institute
state: Maharashtra
city: Bhubaneswar
country: India
facility: All India Institute of Medical Sciences
state: Odisha
city: Hyderabad
country: India
facility: Diabetes Research Center
state: Telangana
city: Rishikesh
country: India
facility: All India Institute of Medical Sciences - Rishikesh
state: Uttarakhand
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Tsuchiura
country: Japan
facility: Tsuchiura Medical & Health Care Center
state: Ibaraki
city: Ushiku
country: Japan
facility: Noritake Clinic
state: Ibaraki
city: Takamatsu
country: Japan
facility: Olive Takamatsu Medical Clinic
state: Kagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Chuo-ku
country: Japan
facility: The Institute of Medical Science, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
state: Tokyo
city: Tokyo
country: Japan
facility: Shimokitazawa Tomo Clinic
city: Mexico City
country: Mexico
facility: RM Pharma Specialists - Unidad Especializada en Datos
state: Distrito Federal
city: Mexico
country: Mexico
facility: Endocrinologia Especializada
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Diseno y Planeacion en Investigacion Medica - Guadalajara - Calle Amado Nervo
state: Jalisco
city: San Pedro Garza Garcia
country: Mexico
facility: Centro Medico Zambrano Hellion
state: Nuevo León
city: Merida
country: Mexico
facility: Medical Care and Research SA de CV
state: Yucatán
city: Mérida
country: Mexico
facility: Kohler & Milstein Research S.A. De C.V.
state: Yucatán
city: Chihuahua
country: Mexico
facility: Enclifar Ensayos Clínicos Farmacológicos Sc
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health and Wellness Institute
city: Guaynabo
country: Puerto Rico
facility: Isis Clinical Research Center
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: