Clinical trial NCT05971940: A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Official title: A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.


Eligibility criteria: Inclusion Criteria:

* Have Type 2 Diabetes
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
* Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

* Have Type 1 Diabetes
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have New York Heart Association functional classification IV congestive heart failure.
* Have acute or chronic pancreatitis

Primary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 40
Secondary outcomes:
measure: Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
timeFrame: Week 40
measure: Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
timeFrame: Week 40
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 40
measure: Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
timeFrame: Baseline, Week 40
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 40
measure: Change from Baseline in Non-HDL Cholesterol
timeFrame: Baseline, Week 40
measure: Percentage Change from Baseline in Triglycerides
timeFrame: Baseline, Week 40
measure: Percentage of Participants Who Achieved Weight Loss of ≥5%
timeFrame: Week 40
measure: Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
timeFrame: Baseline, Week 40
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Syed Research Consultants Llc
state: Alabama
city: Surprise
country: United States
facility: Epic Medical Research - Surprise
state: Arizona
city: Tucson
country: United States
facility: Quality of Life Medical & Research Center
state: Arizona
city: Escondido
country: United States
facility: Neighborhood Healthcare Institute of Health
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: Norco
country: United States
facility: Infinity Clinical Research - Norco
state: California
city: San Ramon
country: United States
facility: Norcal Endocrinology & Internal Medicine
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Cromwell
country: United States
facility: Connecticut Clinical Research - Cromwell
state: Connecticut
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group
state: Florida
city: DeLand
country: United States
facility: Hillcrest Medical Research
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Global Health Research Center, Inc.
state: Florida
city: Ocoee
country: United States
facility: West Orange Endocrinology
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Family First Medical Center
state: Idaho
city: Muncie
country: United States
facility: American Health Network of Indiana, LLC - Muncie
state: Indiana
city: Wichita
country: United States
facility: Tekton Research - Wichita
state: Kansas
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Dearborn
country: United States
facility: Revival Research Institute
state: Michigan
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Brooklyn
country: United States
facility: Ellipsis Research Group - Brooklyn - 7th Street
state: New York
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: New Bern
country: United States
facility: Lucas Research - New Bern
state: North Carolina
city: Dublin
country: United States
facility: Centricity Research Dublin Multispecialty
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic, P.C.
state: Oregon
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians
state: Pennsylvania
city: Greenville
country: United States
facility: The Research Center of The Upstate
state: South Carolina
city: Lancaster
country: United States
facility: MDFirst Research, LLC
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Endocrine Ips, Pllc
state: Texas
city: Houston
country: United States
facility: Amir A Hassan, MD, PA
state: Texas
city: Burke
country: United States
facility: Burke Internal Medicine and Research
state: Virginia
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: Luhe Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Pinggu District Hospital
state: Beijing
city: Foshan
country: China
facility: Shunde Hospital of Southern Medical Univesity
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Municipal Central Hospital
state: Guangdong
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Nanyang
country: China
facility: Nanyang First People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Pudong New Area People's Hospital Shanghai
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Baroda
country: India
facility: GMERS Medical College and General Hospital
state: Gujarat
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospitals
state: Karnataka
city: Bangalore
country: India
facility: Medstar Speciality Hospital
state: Karnataka
city: Mumbai
country: India
facility: BSES MG Hospital
state: Maharashtra
city: Nagpur
country: India
facility: All India Institute of Medical Sciences (AIIMS) - Nagpur
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation - Ruby Hall Clinic
state: Maharashtra
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Hyderabad
country: India
facility: Kumudini Devi Diabetes Research Center
state: Telangana
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
state: West Bengal
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Kitakyushu
country: Japan
facility: Steel Memorial Yahata Hospital
state: Fukuoka
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Mito
country: Japan
facility: MinamiAkatsukaClinic
state: Ibaraki
city: Zentsuji
country: Japan
facility: Iwamoto Clinic
state: Kagawa
city: Chigasaki
country: Japan
facility: Hayashi Diabetes Internal Medicine Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes 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: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Kumamoto
country: Japan
facility: Morinaga Ueno Clinic
city: Oita
country: Japan
facility: Abe Clinic
city: Guadalajara
country: Mexico
facility: Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
state: Jalisco
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medica Integral
state: Jalisco
city: Guadalajara
country: Mexico
facility: Salud Cardiovascular
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Investigacion Medica de Occidente, S.C.
state: Jalisco
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
city: Querétaro
country: Mexico
facility: PanAmerican Clinical Research - Querétaro - Avenida Antea
city: Veracruz
country: Mexico
facility: Instituto Veracruzano en Investigación Clínica S.C.
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Dorado
country: Puerto Rico
facility: Puerto Rico Health Institute
city: San Juan
country: Puerto Rico
facility: Advance Medical 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: