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

Primary Purpose

Type 2 Diabetes

Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Orforglipron
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nakayama Clinic
  • Shinkashiwa ClinicRecruiting
  • Kashiwa City HospitalRecruiting
  • Tokuyama ClinicRecruiting
  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
  • Steel Memorial Yawata HospitalRecruiting
  • Hasegawa Medical ClinicRecruiting
  • Odori DiabetesRecruiting
  • Matsuda Clinic
  • Nakamoto Internal Medicine Clinic
  • MinamiAkatsukaClinic
  • Nakakinen clinic
  • Nishiyamadou Keiwa Hospital
  • Taya Clinic Koueikai Medical CorporationRecruiting
  • Takai Internal Medicine ClinicRecruiting
  • Shonan Takai Clinic
  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes ClinicRecruiting
  • Yokohama Minoru ClinicRecruiting
  • Yokkaichi Diabetes ClinicRecruiting
  • Gibo Hepatology ClinicRecruiting
  • Shiraiwa Medical Clinic
  • Kitada Clinic
  • Medical Corporation Heishinkai OCROM ClinicRecruiting
  • OHAMA Diabetes Clinic
  • Sugiura Internal Medicine Clinic
  • The Institute for Adult Disease, Asahi Life FoundationRecruiting
  • Tokyo-Eki Center-building Clinic
  • Fukuwa Clinic
  • Hachioji Diabetes Clinic
  • Kanno Naika
  • Heishinkai Medical Group ToCROM ClinicRecruiting
  • Medical Corporation Tao Internal Medicine ClinicRecruiting
  • Fujii ClinicRecruiting
  • Tashiro Endocrinology Clinic
  • Morinaga Ueno Clinic
  • Jinnouchi Hospital
  • Heiwadai HospitalRecruiting
  • Abe ClinicRecruiting
  • Kansai Electric Power HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Orforglipron Dose 1

Orforglipron Dose 2

Orforglipron Dose 3

Arm Description

Participants will receive orforglipron administered orally.

Participants will receive orforglipron administered orally.

Participants will receive orforglipron administered orally.

Outcomes

Primary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT06010004
Brief Title
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 1, 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
June 4, 2025 (Anticipated)
Study Completion Date
June 4, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
399 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Orforglipron Dose 1
Arm Type
Experimental
Arm Description
Participants will receive orforglipron administered orally.
Arm Title
Orforglipron Dose 2
Arm Type
Experimental
Arm Description
Participants will receive orforglipron administered orally.
Arm Title
Orforglipron Dose 3
Arm Type
Experimental
Arm Description
Participants will receive orforglipron administered orally.
Intervention Type
Drug
Intervention Name(s)
Orforglipron
Other Intervention Name(s)
LY3502970
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Baseline through Week 52
Secondary Outcome Measure Information:
Title
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 52
Title
Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)
Time Frame
Week 52
Title
Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)
Time Frame
Week 52
Title
Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)
Time Frame
Week 52
Title
Change from Baseline in Fasting Serum Glucose
Time Frame
Baseline, Week 52
Title
Change from Baseline in Body Weight
Time Frame
Baseline, Week 52
Title
Percentage of Participants who Achieve Weight Loss of ≥5%
Time Frame
Week 52
Title
Percentage of Participants who Achieve Weight Loss of ≥10%
Time Frame
Week 52
Title
Percentage of Participants who Achieve Weight Loss of ≥15%
Time Frame
Week 52
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 52
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 52
Title
Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or Phone: 1-317-615-4559
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Nakayama Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
456-0058
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikihiro Nakayama
Facility Name
Shinkashiwa Clinic
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0084
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0471994771
First Name & Middle Initial & Last Name & Degree
Noriko Sakamoto
Facility Name
Kashiwa City Hospital
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-0825
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81471342000
First Name & Middle Initial & Last Name & Degree
Takeshi Inazawa
Facility Name
Tokuyama Clinic
City
Mihama-ku,Chiba City
State/Province
Chiba
ZIP/Postal Code
261-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81432396539
First Name & Middle Initial & Last Name & Degree
Takahiko Tokuyama
Facility Name
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
116099
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tetsuji Niiya
Facility Name
Steel Memorial Yawata Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
805-8508
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udai Nakamura
Facility Name
Hasegawa Medical Clinic
City
Chitose
State/Province
Hokkaido
ZIP/Postal Code
066-0032
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Hasegawa
Facility Name
Odori Diabetes
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0112050811
First Name & Middle Initial & Last Name & Degree
hikaru kamoshima
Facility Name
Matsuda Clinic
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
651-2135
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomokazu Matsuda
Facility Name
Nakamoto Internal Medicine Clinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
310-0826
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shinya nakamoto
Facility Name
MinamiAkatsukaClinic
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4153
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideo Takahashi
Facility Name
Nakakinen clinic
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0113
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Takeshi Osonoi
Facility Name
Nishiyamadou Keiwa Hospital
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0133
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumiko Hasumi
Facility Name
Taya Clinic Koueikai Medical Corporation
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0298232636
First Name & Middle Initial & Last Name & Degree
Koichi Taya
Facility Name
Takai Internal Medicine Clinic
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0056
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masahiko Takai
Facility Name
Shonan Takai Clinic
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-0055
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuninobu Takai
Facility Name
Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
City
Yamato-shi
State/Province
Kanagawa
ZIP/Postal Code
242-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81462717410
First Name & Middle Initial & Last Name & Degree
Taro Asakura
Facility Name
Yokohama Minoru Clinic
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
232-0064
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chino Nakamura
Facility Name
Yokkaichi Diabetes Clinic
City
Yokkaichi
State/Province
Mie
ZIP/Postal Code
510-0829
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81593284109
First Name & Middle Initial & Last Name & Degree
Ryuichi Mizubayashi
Facility Name
Gibo Hepatology Clinic
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
399-0036
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81263576060
First Name & Middle Initial & Last Name & Degree
Yukio Gibo
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Shiraiwa
Facility Name
Kitada Clinic
City
Osaka-city
State/Province
Osaka
ZIP/Postal Code
538-0044
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirokazu Kitada
Facility Name
Medical Corporation Heishinkai OCROM Clinic
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0663308810
First Name & Middle Initial & Last Name & Degree
Satoshi Inoue
Facility Name
OHAMA Diabetes Clinic
City
Kawaguchi
State/Province
Saitama
ZIP/Postal Code
332-0015
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Ohama
Facility Name
Sugiura Internal Medicine Clinic
City
Soka
State/Province
Saitama
ZIP/Postal Code
340-0034
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatsushi Sugiura
Facility Name
The Institute for Adult Disease, Asahi Life Foundation
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0002
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yukiko Onishi
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arihiro Kiyosue
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasushi Fukushima
Facility Name
Hachioji Diabetes Clinic
City
Hachioji-shi
State/Province
Tokyo
ZIP/Postal Code
192-0083
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naoyuki Yamamoto
Facility Name
Kanno Naika
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-0013
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kazuo Kanno
Facility Name
Heishinkai Medical Group ToCROM Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osamu Matsuoka
Facility Name
Medical Corporation Tao Internal Medicine Clinic
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-0047
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0836373310
First Name & Middle Initial & Last Name & Degree
Tsuyoshi Tao
Facility Name
Fujii Clinic
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-0049
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0836320760
First Name & Middle Initial & Last Name & Degree
Shinya Fujii
Facility Name
Tashiro Endocrinology Clinic
City
Fukuoka
ZIP/Postal Code
814-0153
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naotaka Tashiro
Facility Name
Morinaga Ueno Clinic
City
Kumamoto
ZIP/Postal Code
860-0863
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroshi Morinaga
Facility Name
Jinnouchi Hospital
City
Kumamoto
ZIP/Postal Code
862-0976
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hideaki Jinnouchi
Facility Name
Heiwadai Hospital
City
Miyazaki
ZIP/Postal Code
880-0034
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81985242605
First Name & Middle Initial & Last Name & Degree
Shuji Nakamura
Facility Name
Abe Clinic
City
Oita
ZIP/Postal Code
870-0039
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katsushige Abe
Facility Name
Kansai Electric Power Hospital
City
Osaka
ZIP/Postal Code
553-0003
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoshiyuki Initials Hamamoto

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/419717
Description
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)

Learn more about this trial

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

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