Fact CheckerSign in

NCT06010004CompletedPhase 3

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

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)

Source: ClinicalTrials.gov · Last updated 30 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
401 (actual)
First submitted
21 Aug 2023
Start date
28 Sept 2023
Primary completion date
5 Jun 2025
Lead sponsor
Eli Lilly and Company
NCT number
NCT06010004

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 401
  • From 28 Sept 2023 to the primary completion date, 5 Jun 2025
  • 40 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

  • Have Type 1 Diabetes (T1D).
  • Have New York Heart Association functional classification IV congestive heart failure.
  • Have acute or chronic hepatitis and pancreatitis

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seiwa Clinic
Coordinator of this site? Confirm its status
Adachi-kuJapanUnknown status
Hasegawa Medical Clinic
Coordinator of this site? Confirm its status
ChitoseJapanUnknown status
The Institute for Adult Disease, Asahi Life Foundation
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Fukuwa Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Tokyo-Eki Center-building Clinic
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Tashiro Endocrinology Clinic
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
Hachioji Diabetes Clinic
Coordinator of this site? Confirm its status
Hachioji-shiJapanUnknown status
Shonan Takai Clinic
Coordinator of this site? Confirm its status
KamakuraJapanUnknown status
Takai Internal Medicine Clinic
Coordinator of this site? Confirm its status
Kamakura-shiJapanUnknown status
Shiraiwa Medical Clinic
Coordinator of this site? Confirm its status
KashiharaJapanUnknown status
Shinkashiwa Clinic
Coordinator of this site? Confirm its status
KashiwaJapanUnknown status
Kashiwa City Hospital
Coordinator of this site? Confirm its status
KashiwaJapanUnknown status
OHAMA Diabetes Clinic
Coordinator of this site? Confirm its status
KawaguchiJapanUnknown status
Steel Memorial Yawata Hospital
Coordinator of this site? Confirm its status
KitakyushuJapanUnknown status
Matsuda Clinic
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Jinnouchi Hospital
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
Morinaga Ueno Clinic
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
Gibo Hepatology Clinic
Coordinator of this site? Confirm its status
MatsumotoJapanUnknown status
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
Coordinator of this site? Confirm its status
MatsuyamaJapanUnknown status
Tokuyama Clinic
Coordinator of this site? Confirm its status
Mihama-ku,Chiba CityJapanUnknown status
Kanno Naika
Coordinator of this site? Confirm its status
MitakaJapanUnknown status
MinamiAkatsukaClinic
Coordinator of this site? Confirm its status
MitoJapanUnknown status
Nakamoto Internal Medicine Clinic
Coordinator of this site? Confirm its status
MitoJapanUnknown status
Heiwadai Hospital
Coordinator of this site? Confirm its status
MiyazakiJapanUnknown status
Nakayama Clinic
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
Nishiyamadou Keiwa Hospital
Coordinator of this site? Confirm its status
NakaJapanUnknown status
Nakakinen clinic
Coordinator of this site? Confirm its status
NakaJapanUnknown status
Abe Clinic
Coordinator of this site? Confirm its status
ŌitaJapanUnknown status
Kitada Clinic
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Kansai Electric Power Hospital
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Odori Diabetes
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Heishinkai Medical Group ToCROM Clinic
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Sugiura Internal Medicine Clinic
Coordinator of this site? Confirm its status
SōkaJapanUnknown status
Medical Corporation Heishinkai OCROM Clinic
Coordinator of this site? Confirm its status
Suita-shiJapanUnknown status
Taya Clinic Koueikai Medical Corporation
Coordinator of this site? Confirm its status
TsuchiuraJapanUnknown status
Medical Corporation Tao Internal Medicine Clinic
Coordinator of this site? Confirm its status
UbeJapanUnknown status
Fujii Clinic
Coordinator of this site? Confirm its status
UbeJapanUnknown status
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
Coordinator of this site? Confirm its status
Yamato-shiJapanUnknown status
Yokkaichi Diabetes Clinic
Coordinator of this site? Confirm its status
YokkaichiJapanUnknown status
Yokohama Minoru Clinic
Coordinator of this site? Confirm its status
YokohamaJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.