Clinical trial NCT06010004: A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-24
Enrollment: 399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline through Week 52
Secondary outcomes:
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 52
measure: Percentage of Participants who Achieve HbA1c <7.0% (<53 mmol/mol)
timeFrame: Week 52
measure: Percentage of Participants who Achieve HbA1c ≤6.5% (<48 mmol/mol)
timeFrame: Week 52
measure: Percentage of Participants who Achieve HbA1c <5.7% (<39 mmol/mol)
timeFrame: Week 52
measure: Change from Baseline in Fasting Serum Glucose
timeFrame: Baseline, Week 52
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 52
measure: Percentage of Participants who Achieve Weight Loss of ≥5%
timeFrame: Week 52
measure: Percentage of Participants who Achieve Weight Loss of ≥10%
timeFrame: Week 52
measure: Percentage of Participants who Achieve Weight Loss of ≥15%
timeFrame: Week 52
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 52
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 52
measure: Change from Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)
timeFrame: Baseline, Week 52
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nakayama Clinic
state: Aichi
city: Kashiwa
country: Japan
facility: Shinkashiwa Clinic
state: Chiba
city: Kashiwa
country: Japan
facility: Kashiwa City Hospital
state: Chiba
city: Mihama-ku,Chiba City
country: Japan
facility: Tokuyama Clinic
state: Chiba
city: Matsuyama
country: Japan
facility: Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
state: Ehime
city: Kitakyushu
country: Japan
facility: Steel Memorial Yawata Hospital
state: Fukuoka
city: Chitose
country: Japan
facility: Hasegawa Medical Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Odori Diabetes
state: Hokkaido
city: Kobe
country: Japan
facility: Matsuda Clinic
state: Hyogo
city: Mito
country: Japan
facility: Nakamoto Internal Medicine Clinic
state: Ibaraki
city: Mito
country: Japan
facility: MinamiAkatsukaClinic
state: Ibaraki
city: Naka
country: Japan
facility: Nakakinen clinic
state: Ibaraki
city: Naka
country: Japan
facility: Nishiyamadou Keiwa Hospital
state: Ibaraki
city: Tsuchiura
country: Japan
facility: Taya Clinic Koueikai Medical Corporation
state: Ibaraki
city: Kamakura-shi
country: Japan
facility: Takai Internal Medicine Clinic
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Takai Clinic
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minoru Clinic
state: Kanagawa
city: Yokkaichi
country: Japan
facility: Yokkaichi Diabetes Clinic
state: Mie
city: Matsumoto
country: Japan
facility: Gibo Hepatology Clinic
state: Nagano
city: Kashiwara
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Osaka-city
country: Japan
facility: Kitada Clinic
state: Osaka
city: Suita-shi
country: Japan
facility: Medical Corporation Heishinkai OCROM Clinic
state: Osaka
city: Kawaguchi
country: Japan
facility: OHAMA Diabetes Clinic
state: Saitama
city: Soka
country: Japan
facility: Sugiura Internal Medicine Clinic
state: Saitama
city: Adachi-ku
country: Japan
facility: Seiwa Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: The Institute for Adult Disease, Asahi Life Foundation
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo-Eki Center-building Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Fukuwa Clinic
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Hachioji Diabetes Clinic
state: Tokyo
city: Mitaka
country: Japan
facility: Kanno Naika
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Heishinkai Medical Group ToCROM Clinic
state: Tokyo
city: Ube
country: Japan
facility: Medical Corporation Tao Internal Medicine Clinic
state: Yamaguchi
city: Ube
country: Japan
facility: Fujii Clinic
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Tashiro Endocrinology Clinic
city: Kumamoto
country: Japan
facility: Morinaga Ueno Clinic
city: Kumamoto
country: Japan
facility: Jinnouchi Hospital
city: Miyazaki
country: Japan
facility: Heiwadai Hospital
city: Oita
country: Japan
facility: Abe Clinic
city: Osaka
country: Japan
facility: Kansai Electric Power Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: