A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

Type 2 Diabetes Clinical Trial

— ACHIEVE-1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05971940
• Other study ID #: 18564
• Secondary ID: J2A-MC-GZGTU1111
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 9, 2023
• Est. completion date: April 9, 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 520
• Est. completion date: April 9, 2025
• Est. primary completion date: April 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Orforglipron
Administered orally.
• Placebo
Administered orally

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing
China	Beijing Pinggu District Hospital	Beijing	Beijing
China	Luhe Hospital	Beijing	Beijing
China	West China Hospital of Sichuan University	Cheng Du	Sichuan
China	Shunde Hospital of Southern Medical Univesity	Foshan	Guangdong
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Huizhou Municipal Central Hospital	Huizhou	Guangdong
China	Jinan Central Hospital	Jinan	Shandong
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Nanyang First People's Hospital	Nanyang	Henan
China	Pudong New Area People's Hospital Shanghai	Shanghai	Shanghai
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	The Second Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
India	B. J. Medical College & Civil Hospital	Ahmedabad	Gujarat
India	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka
India	Medstar Speciality Hospital	Bangalore	Karnataka
India	GMERS Medical College and General Hospital	Baroda	Gujarat
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Kumudini Devi Diabetes Research Center	Hyderabad	Telangana
India	Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital	Kolkata	West Bengal
India	BSES MG Hospital	Mumbai	Maharashtra
India	All India Institute of Medical Sciences (AIIMS) - Nagpur	Nagpur	Maharashtra
India	Grant Medical Foundation - Ruby Hall Clinic	Pune	Maharashtra
Japan	Hayashi Diabetes Internal Medicine Clinic	Chigasaki	Kanagawa
Japan	Hasegawa Medical Clinic	Chitose	Hokkaido
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	The Institute for Adult Disease, Asahi Life Foundation	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka
Japan	Morinaga Ueno Clinic	Kumamoto
Japan	Tokuyama Clinic	Mihama-ku,Chiba City	Chiba
Japan	MinamiAkatsukaClinic	Mito	Ibaraki
Japan	Abe Clinic	Oita
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa
Japan	Iwamoto Internal Medicine Clinic	Zentsuji	Kagawa
Mexico	Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos	Chihuahua
Mexico	Centro de Investigacion Medica Integral	Guadalajara	Jalisco
Mexico	Salud Cardiovascular	Guadalajara	Jalisco
Mexico	Unidad de Investigaci?n Cl?nica Cardiometabolica de Occidente	Guadalajara	Jalisco
Mexico	PanAmerican Clinical Research - Querétaro - Avenida Antea	Querétaro
Mexico	FAICIC S. de R.L. de C.V.	Veracruz
Mexico	Instituto Veracruzano en Investigación Clínica S.C.	Veracruz
Mexico	Centro de Investigacion Medica de Occidente, S.C.	Zapopan	Jalisco
Puerto Rico	Puerto Rico Health Institute	Dorado
Puerto Rico	Advance Medical Research Center	San Juan
United States	Billings Clinic	Billings	Montana
United States	Ellipsis Research Group	Brooklyn	New York
United States	Burke Internal Medicine and Research	Burke	Virginia
United States	Invictus Clinical Research Group	Coconut Creek	Florida
United States	The Corvallis Clinic, P.C.	Corvallis	Oregon
United States	Connecticut Clinical Research - Cromwell	Cromwell	Connecticut
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Revival Research Institute - Dearborn	Dearborn	Michigan
United States	Hillcrest Medical Research	DeLand	Florida
United States	Aventiv Research	Dublin	Ohio
United States	Neighborhood Healthcare Institute of Health	Escondido	California
United States	The Research Center of The Upstate	Greenville	South Carolina
United States	Amir A Hassan, MD, PA	Houston	Texas
United States	Endocrine Ips, Pllc	Houston	Texas
United States	Juno Research	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Family First Medical Center	Idaho Falls	Idaho
United States	The Jackson Clinic	Jackson	Tennessee
United States	MDFirst Research, LLC	Lancaster	South Carolina
United States	Ark Clinical Research	Long Beach	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	K2 Medical Research	Maitland	Florida
United States	Central New York Clinical Research	Manlius	New York
United States	Global Health Research Center, Inc.	Miami Lakes	Florida
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	American Health Network of IN, LLC	Muncie	Indiana
United States	Lucas Research - New Bern	New Bern	North Carolina
United States	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana
United States	Infinity Clinical Research - Norco	Norco	California
United States	Intend Research, LLC	Norman	Oklahoma
United States	West Orange Endocrinology	Ocoee	Florida
United States	Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair	Pittsburgh	Pennsylvania
United States	Norcal Endocrinology & Internal Medicine	San Ramon	California
United States	Syed Research Consultants Llc	Sheffield	Alabama
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Epic Medical Research - Surprise	Surprise	Arizona
United States	Quality of Life Medical & Research Center	Tucson	Arizona
United States	University Clinical Investigators, Inc.	Tustin	California
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Preferred Primary Care Physicians	Uniontown	Pennsylvania
United States	Tekton Research - Wichita	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  China,  India,  Japan,  Mexico,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 40
Secondary	Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)		Week 40
Secondary	Percentage of Participants with an HbA1c target value of =6.5% (48 mmol/mol)		Week 40
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 40
Secondary	Percentage Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Change from Baseline in Body Weight		Baseline, Week 40
Secondary	Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)		Baseline, Week 40
Secondary	Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 40
Secondary	Change from Baseline in Non-HDL Cholesterol		Baseline, Week 40
Secondary	Percentage Change from Baseline in Triglycerides		Baseline, Week 40
Secondary	Percentage of Participants Who Achieved Weight Loss of =5%		Week 40
Secondary	Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores		Baseline, Week 40

External Links

•   A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)