Clinical trial NCT06972472: A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Type 2 Diabetes
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: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obesity
Overweight
Type 2 Diabetes
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 improve glycemic control in participants with obesity or with overweight and 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) ≥25 kilograms per square meter (kg/m2) at screening
* Have type 2 diabetes
* Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening
* Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion Criteria:

* Have type 1 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: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline up to 72 weeks
measure: Change from Baseline in HbA1c at Week 72
timeFrame: Baseline, Week 72
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline up to 72 weeks
measure: Percentage of Participants Achieving HbA1c of <7.0%
timeFrame: Baseline up to 72 weeks
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 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: Accel Research Sites - NeuroStudies Clinical Research Unit
state: Georgia
city: Decatur
country: United States
facility: Care Access - Decatur
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: