Back to resultsA Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease (ATTAIN-J)
Primary Purpose
Obesity
Status
Recruiting
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Orforglipron
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Overweight, Metabolism and Nutrition Disorder
Eligibility Criteria
Inclusion Criteria: Participants with a BMI ≥27 kg/m² and <35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants). Have a history of at least one self-reported unsuccessful dietary effort to lose body weight. Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. No male contraception is required except in compliance with specific local government study requirements. Exclusion Criteria: For participants with Type 2 Diabetes (T2D): Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D. Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening. Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening. Have a known clinically significant gastric emptying abnormality. For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %. Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening. Have chronic kidney disease. Have lupus or rheumatoid arthritis. Have the following cardiovascular conditions within 90 days prior to screening. Have acute or chronic hepatitis.
Sites / Locations
- Nishiyamadou Keiwa HospitalRecruiting
- Tsuchiura Beryl ClinicRecruiting
- Ohishi Internal Medicine ClinicRecruiting
- Takai Internal Medicine ClinicRecruiting
- Shonan Takai ClinicRecruiting
- Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes ClinicRecruiting
- Shiraiwa Medical ClinicRecruiting
- Medical Corporation Heishinkai OCROM ClinicRecruiting
- Yotsuya Medical CubeRecruiting
- Nihonbashi Sakura ClinicRecruiting
- Tokyo-Eki Center-building ClinicRecruiting
- Fukuwa ClinicRecruiting
- Heishinkai Medical Group ToCROM ClinicRecruiting
- Hiroshima Station ClinicRecruiting
- AMC Nishiumeda ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Orforglipron Dose 1
Orforglipron Dose 2
Orforglipron Dose 3
Placebo
Arm Description
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
Participants will receive orforglipron orally.
Participants will receive placebo.
Outcomes
Primary Outcome Measures
Mean Percent Change in Body Weight
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Secondary Outcome Measures
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Mean Change from Baseline in Body Mass Index (BMI)
Percentage of Participants Who Had Improvements in Hypertension
Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)
Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):
Mean Change from Baseline in Visceral Adipose Tissue (VAT)
Mean Change from Baseline in Waist Circumference at Umbilical Level
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Mean Change from Baseline in non-High Density Lipoprotein (HDL)
Mean Change from Baseline in HDL
Mean Change from Baseline in Triglycerides
Mean Change from Baseline in Fasting Glucose
Mean Change from Baseline in Hemoglobin A1c (HbA1c)
Mean Change from Baseline in High-sensitivity C-reactive Protein
Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score
Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)
Pharmacokinetics (PK): Plasma Concentration of Orforglipron
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05931380
Brief Title
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
Acronym
ATTAIN-J
Official Title
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Japanese Adult Participants With Obesity Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
June 3, 2025 (Anticipated)
Study Completion Date
July 1, 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 main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Metabolism and Nutrition Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Orforglipron Dose 1
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Orforglipron Dose 2
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Orforglipron Dose 3
Arm Type
Experimental
Arm Description
Participants will receive orforglipron orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Orforglipron
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Mean Percent Change in Body Weight
Time Frame
Baseline, Week 72
Title
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Time Frame
Baseline to Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Time Frame
Baseline to Week 72
Title
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Time Frame
Baseline to Week 72
Title
Percentage of Participants Who Achieve ≥20% Body Weight Reduction
Time Frame
Baseline to Week 72
Title
Mean Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 72
Title
Percentage of Participants Who Had Improvements in Hypertension
Time Frame
Baseline to Week 72
Title
Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)
Time Frame
Baseline to Week 72
Title
Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):
Time Frame
Baseline to Week 72
Title
Mean Change from Baseline in Visceral Adipose Tissue (VAT)
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Waist Circumference at Umbilical Level
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in non-High Density Lipoprotein (HDL)
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in HDL
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Triglycerides
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Fasting Glucose
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in High-sensitivity C-reactive Protein
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Time Frame
Baseline, Week 72
Title
Mean Change from Baseline in IMPACT of Weight on Quality-of-Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function, Physical, and Psychosocial Composite Score
Time Frame
Baseline, Week 72
Title
Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)
Time Frame
Baseline to Week 72
Title
Pharmacokinetics (PK): Plasma Concentration of Orforglipron
Time Frame
Baseline to Week 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a BMI ≥27 kg/m² and <35 kg/m² and at least 2 obesity-related health problems (treated or untreated), OR a BMI ≥35 kg/m² and at least 1 obesity-related health problem (treated or untreated). At least one obesity-related health problem should be hypertension, dyslipidemia or T2D (approximately 25% of participants).
Have a history of at least one self-reported unsuccessful dietary effort to lose body weight.
Males and females may participate in this trial. Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
No male contraception is required except in compliance with specific local government study requirements.
Exclusion Criteria:
For participants with Type 2 Diabetes (T2D):
Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within the 180 days prior to screening.
Have renal impairment measured as estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m², calculated by Japanese Society of Nephrology coefficient-modified chronic kidney disease-epidemiology equation during screening.
Have a known clinically significant gastric emptying abnormality.
For participants without Type 2 diabetes (T2D): Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %.
Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
Have chronic kidney disease.
Have lupus or rheumatoid arthritis.
Have the following cardiovascular conditions within 90 days prior to screening.
Have acute or chronic hepatitis.
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
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
Nishiyamadou Keiwa Hospital
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0133
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0292955121
First Name & Middle Initial & Last Name & Degree
Sumiko Hasumi
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81298353002
First Name & Middle Initial & Last Name & Degree
Kota Yamada
Facility Name
Ohishi Internal Medicine Clinic
City
Tsuchiura
State/Province
Ibaraki
ZIP/Postal Code
300-0835
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81298350014
First Name & Middle Initial & Last Name & Degree
Akira Ohishi
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuninobu Takai
Facility Name
Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0302
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
81427011041
First Name & Middle Initial & Last Name & Degree
Mizuki Kaneshiro
Facility Name
Shiraiwa Medical Clinic
City
Kashiwara
State/Province
Osaka
ZIP/Postal Code
582-0005
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toshihiko Shiraiwa
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
Yotsuya Medical Cube
City
Chiyoda
State/Province
Tokyo
ZIP/Postal Code
102-0084
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akio Kanazawa
Facility Name
Nihonbashi Sakura Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0025
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kumie Ito
Facility Name
Tokyo-Eki Center-building Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
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
Recruiting
Facility Contact:
Phone
81362623751
First Name & Middle Initial & Last Name & Degree
Yasushi Fukushima
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
Hiroshima Station Clinic
City
Hiroshima
ZIP/Postal Code
732-0053
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiyotaka Ishida
Facility Name
AMC Nishiumeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
Phone
0647975660
First Name & Middle Initial & Last Name & Degree
Yozo Kanamaru
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/
Learn more about this trial
A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease
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