A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

— ACHIEVE-J  

Official title:

A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06010004
• Other study ID #: 18745
• Secondary ID: J2A-JE-GZPE
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 28, 2023
• Est. completion date: June 21, 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 purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication.

This study includes 3 periods as follows:

• screening and lead-in period: up to 4 weeks

• treatment period: 52 weeks, including 20 weeks of dose escalation, and

• safety follow-up period: 2 weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 399
• Est. completion date: June 21, 2025
• Est. primary completion date: June 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have Type 2 Diabetes (T2D)

• Have HbA1c =7.0% (=53 mmol/mol) to =10.5% (=91 mmol/mol) as determined by the central laboratory at screening.

• 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 BMI =23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

• Have Type 1 Diabetes (T1D).

• Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.

• Have New York Heart Association functional classification IV congestive heart failure.

• Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

• acute myocardial infarction

• cerebrovascular accident (stroke), or

• hospitalization for congestive heart failure

• Have acute or chronic hepatitis and pancreatitis

Related Conditions & MeSH terms

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

Intervention

Drug:
• Orforglipron
Administered orally

Locations

Country	Name	City	State
Japan	Seiwa Clinic	Adachi-ku	Tokyo
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	Tashiro Endocrinology Clinic	Fukuoka
Japan	Hachioji Diabetes Clinic	Hachioji-shi	Tokyo
Japan	Shonan Takai Clinic	Kamakura	Kanagawa
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Kashiwa City Hospital	Kashiwa	Chiba
Japan	Shinkashiwa Clinic	Kashiwa	Chiba
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	OHAMA Diabetes Clinic	Kawaguchi	Saitama
Japan	Steel Memorial Yawata Hospital	Kitakyushu	Fukuoka
Japan	Matsuda Clinic	Kobe	Hyogo
Japan	Jinnouchi Hospital	Kumamoto
Japan	Morinaga Ueno Clinic	Kumamoto
Japan	Gibo Hepatology Clinic	Matsumoto	Nagano
Japan	Mikannohana Clinic, Diabetes, Endocrinology and Metabolism	Matsuyama	Ehime
Japan	Tokuyama Clinic	Mihama-ku,Chiba City	Chiba
Japan	Kanno Naika	Mitaka	Tokyo
Japan	MinamiAkatsukaClinic	Mito	Ibaraki
Japan	Nakamoto Internal Medicine Clinic	Mito	Ibaraki
Japan	Heiwadai Hospital	Miyazaki
Japan	Nakayama Clinic	Nagoya	Aichi
Japan	Nakakinen clinic	Naka	Ibaraki
Japan	Nishiyamadou Keiwa Hospital	Naka	Ibaraki
Japan	Abe Clinic	Oita
Japan	Kansai Electric Power Hospital	Osaka
Japan	Kitada Clinic	Osaka-city	Osaka
Japan	Odori Diabetes	Sapporo	Hokkaido
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Sugiura Internal Medicine Clinic	Soka	Saitama
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Taya Clinic Koueikai Medical Corporation	Tsuchiura	Ibaraki
Japan	Fujii Clinic	Ube	Yamaguchi
Japan	Medical Corporation Tao Internal Medicine Clinic	Ube	Yamaguchi
Japan	Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic	Yamato-shi	Kanagawa
Japan	Yokkaichi Diabetes Clinic	Yokkaichi	Mie
Japan	Yokohama Minoru Clinic	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Baseline through Week 52
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 52
Secondary	Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)		Week 52
Secondary	Percentage of Participants who Achieve HbA1c =6.5% (<48 mmol/mol)		Week 52
Secondary	Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)		Week 52
Secondary	Change from Baseline in Fasting Serum Glucose		Baseline, Week 52
Secondary	Change from Baseline in Body Weight		Baseline, Week 52
Secondary	Percentage of Participants who Achieve Weight Loss of =5%		Week 52
Secondary	Percentage of Participants who Achieve Weight Loss of =10%		Week 52
Secondary	Percentage of Participants who Achieve Weight Loss of =15%		Week 52
Secondary	Change from Baseline in Waist Circumference		Baseline, Week 52
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 52
Secondary	Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)		Baseline, Week 52

External Links

•   A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)