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

NCT06010004 | Completed Phase 3 FDA Drug

• 2 other identifiers: 18745J2A-JE-GZPE
• Study Type: interventional
• Target: 466
• Locations: 1 country
• Sites: 40

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs)

  Baseline through Week 52

Secondary Outcomes (12)

• 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

Study Arms (3)

Orforglipron Dose 1

EXPERIMENTAL

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Orforglipron Dose 2

EXPERIMENTAL

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Orforglipron Dose 3

EXPERIMENTAL

Participants will receive orforglipron administered orally.

Drug: Orforglipron

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Orforglipron Dose 1; Orforglipron Dose 2; Orforglipron Dose 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (40)

Nakayama Clinic

Nagoya, Aichi-ken, 456-0058, Japan

Location

Shinkashiwa Clinic

Kashiwa, Chiba, 277-0084, Japan

Location

Kashiwa City Hospital

Kashiwa, Chiba, 277-0825, Japan

Location

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, 261-0004, Japan

Location

Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

Matsuyama, Ehime, 790-0034, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu, Fukuoka, 805-8508, Japan

Location

Hasegawa Medical Clinic

Chitose, Hokkaido, 066-0032, Japan

Location

Odori Diabetes

Sapporo, Hokkaido, 060-0001, Japan

Location

Matsuda Clinic

Kobe, Hyōgo, 651-2135, Japan

Location

Nakamoto Internal Medicine Clinic

Mito, Ibaraki, 310-0826, Japan

Location

MinamiAkatsukaClinic

Mito, Ibaraki, 311-4153, Japan

Location

Nakakinen clinic

Naka, Ibaraki, 311-0113, Japan

Location

Nishiyamadou Keiwa Hospital

Naka, Ibaraki, 311-0133, Japan

Location

Taya Clinic Koueikai Medical Corporation

Tsuchiura, Ibaraki, 300-0047, Japan

Location

Shonan Takai Clinic

Kamakura, Kanagawa, 247-0055, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

Yamato-shi, Kanagawa, 242-0004, Japan

Location

Yokohama Minoru Clinic

Yokohama, Kanagawa, 232-0064, Japan

Location

Yokkaichi Diabetes Clinic

Yokkaichi, Mie-ken, 510-0829, Japan

Location

Gibo Hepatology Clinic

Matsumoto, Nagano, 399-0036, Japan

Location

Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan

Location

Kitada Clinic

Osaka, Osaka, 538-0044, Japan

Location

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

OHAMA Diabetes Clinic

Kawaguchi, Saitama, 332-0015, Japan

Location

Sugiura Internal Medicine Clinic

Sōka, Saitama, 340-0015, Japan

Location

Seiwa Clinic

Adachi-ku, Tokyo, 120-0011, Japan

Location

The Institute for Adult Disease, Asahi Life Foundation

Chuo-ku, Tokyo, 103-0002, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Hachioji Diabetes Clinic

Hachioji-shi, Tokyo, 192-0083, Japan

Location

Kanno Naika

Mitaka, Tokyo, 181-0013, Japan

Location

Heishinkai Medical Group ToCROM Clinic

Shinjuku-ku, Tokyo, 160-0008, Japan

Location

Medical Corporation Tao Internal Medicine Clinic

Ube, Yamaguchi, 755-0047, Japan

Location

Fujii Clinic

Ube, Yamaguchi, 755-0049, Japan

Location

Tashiro Endocrinology Clinic

Fukuoka, 814-0153, Japan

Location

Morinaga Ueno Clinic

Kumamoto, 860-0863, Japan

Location

Jinnouchi Hospital

Kumamoto, 862-0976, Japan

Location

Heiwadai Hospital

Miyazaki, 880-0034, Japan

Location

Kansai Electric Power Hospital

Osaka, 553-0003, Japan

Location

Abe Clinic

Ōita, 870-0039, Japan

Location

Related 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)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 24, 2023
• Study Start: September 28, 2023
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

JP (40)