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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Orforglipron

• Study Type: Interventional
• Enrollment (Actual): 466
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 814-0153
    • Tashiro Endocrinology Clinic
  • Kumamoto, Japan, 862-0976
    • Jinnouchi Hospital
  • Kumamoto, Japan, 860-0863
    • Morinaga Ueno Clinic
  • Miyazaki, Japan, 880-0034
    • Heiwadai Hospital
  • Oita, Japan, 870-0039
    • Abe Clinic
  • Osaka, Japan, 553-0003
    • Kansai Electric Power Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 456-0058
      • Nakayama Clinic
  • Chiba
    • Kashiwa, Chiba, Japan, 277-0825
      • Kashiwa City Hospital
    • Kashiwa, Chiba, Japan, 277-0084
      • Shinkashiwa Clinic
    • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
      • Tokuyama Clinic
  • Ehime
    • Matsuyama, Ehime, Japan, 790-0034
      • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 805-8508
      • Steel Memorial Yawata Hospital
  • Hokkaido
    • Chitose, Hokkaido, Japan, 066-0032
      • Hasegawa Medical Clinic
    • Sapporo, Hokkaido, Japan, 060-0001
      • Odori Diabetes
  • Hyogo
    • Kobe, Hyogo, Japan, 651-2135
      • Matsuda Clinic
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0826
      • Nakamoto Internal Medicine Clinic
    • Mito, Ibaraki, Japan, 311-4153
      • MinamiAkatsukaClinic
    • Naka, Ibaraki, Japan, 311-0113
      • Nakakinen clinic
    • Naka, Ibaraki, Japan, 311-0133
      • Nishiyamadou Keiwa Hospital
    • Tsuchiura, Ibaraki, Japan, 300-0047
      • Taya Clinic Koueikai Medical Corporation
  • Kanagawa
    • Kamakura, Kanagawa, Japan, 247-0055
      • Shonan Takai Clinic
    • Kamakura-shi, Kanagawa, Japan, 247-0056
      • Takai Internal Medicine Clinic
    • Yamato-shi, Kanagawa, Japan, 242-0004
      • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
    • Yokohama, Kanagawa, Japan, 232-0064
      • Yokohama Minoru Clinic
  • Mie
    • Yokkaichi, Mie, Japan, 510-0829
      • Yokkaichi Diabetes Clinic
  • Nagano
    • Matsumoto, Nagano, Japan, 399-0036
      • Gibo Hepatology Clinic
  • Osaka
    • Kashiwara, Osaka, Japan, 582-0005
      • Shiraiwa Medical Clinic
    • Osaka-city, Osaka, Japan, 538-0044
      • Kitada Clinic
    • Suita-shi, Osaka, Japan, 565-0853
      • Medical Corporation Heishinkai OCROM Clinic
  • Saitama
    • Kawaguchi, Saitama, Japan, 332-0015
      • OHAMA Diabetes Clinic
    • Soka, Saitama, Japan, 340-0015
      • Sugiura Internal Medicine Clinic
  • Tokyo
    • Adachi-ku, Tokyo, Japan, 120-0011
      • Seiwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0027
      • Tokyo-Eki Center-building Clinic
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Fukuwa Clinic
    • Chuo-ku, Tokyo, Japan, 103-0002
      • The Institute for Adult Disease, Asahi Life Foundation
    • Hachioji-shi, Tokyo, Japan, 192-0083
      • Hachioji Diabetes Clinic
    • Mitaka, Tokyo, Japan, 181-0013
      • Kanno Naika
    • Shinjuku-ku, Tokyo, Japan, 160-0008
      • Heishinkai Medical Group ToCROM Clinic
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-0047
      • Medical Corporation Tao Internal Medicine Clinic
    • Ube, Yamaguchi, Japan, 755-0049
      • Fujii Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orforglipron Dose 1; Participants will receive orforglipron administered orally.	Drug: Orforglipron; Administered orally; Other Names: LY3502970
Experimental: Orforglipron Dose 2; Participants will receive orforglipron administered orally.	Drug: Orforglipron; Administered orally; Other Names: LY3502970
Experimental: Orforglipron Dose 3; Participants will receive orforglipron administered orally.	Drug: Orforglipron; Administered orally; Other Names: LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)	Baseline through Week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Body Weight	Baseline, Week 52
Change from Baseline in Hemoglobin A1c (HbA1c)	Baseline, Week 52
Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)	Week 52
Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)	Week 52
Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)	Week 52
Change from Baseline in Fasting Serum Glucose	Baseline, Week 52
Percentage of Participants who Achieve Weight Loss of ≥5%	Week 52
Percentage of Participants who Achieve Weight Loss of ≥10%	Week 52
Percentage of Participants who Achieve Weight Loss of ≥15%	Week 52
Change from Baseline in Waist Circumference	Baseline, Week 52
Change from Baseline in Body Mass Index (BMI)	Baseline, Week 52
Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)	Baseline, Week 52

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

Helpful 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)

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Actual): June 5, 2025
• Study Completion (Actual): June 5, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 18745; J2A-JE-GZPE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes