A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

Obesity Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05931380
• Other study ID #: 18744
• Secondary ID: J2A-JE-GZPD
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 31, 2023
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Orforglipron
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Japan	Yotsuya Medical Cube	Chiyoda	Tokyo
Japan	Fukuwa Clinic	Chuo-ku	Tokyo
Japan	Nihonbashi Sakura Clinic	Chuo-ku	Tokyo
Japan	Tokyo-Eki Center-building Clinic	Chuo-ku	Tokyo
Japan	Hiroshima Station Clinic	Hiroshima
Japan	Shonan Takai Clinic	Kamakura	Kanagawa
Japan	Takai Internal Medicine Clinic	Kamakura-shi	Kanagawa
Japan	Shiraiwa Medical Clinic	Kashiwara	Osaka
Japan	Sugiura Clinic	Kawaguchi	Saitama
Japan	Nishiyamadou Keiwa Hospital	Naka	Ibaraki
Japan	AMC Nishiumeda Clinic	Osaka
Japan	Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic	Sagamihara	Kanagawa
Japan	Heishinkai Medical Group ToCROM Clinic	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Ohishi Internal Medicine Clinic	Tsuchiura	Ibaraki
Japan	Tsuchiura Beryl Clinic	Tsuchiura	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Body Weight		Baseline, Week 72
Primary	Percentage of Participants Who Achieve =5% Body Weight Reduction		Baseline to Week 72
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Baseline to Week 72
Secondary	Percentage of Participants Who Achieve =15% Body Weight Reduction		Baseline to Week 72
Secondary	Percentage of Participants Who Achieve =20% Body Weight Reduction		Baseline to Week 72
Secondary	Mean Change from Baseline in Body Mass Index (BMI)		Baseline, Week 72
Secondary	Percentage of Participants Who Had Improvements in Hypertension		Baseline to Week 72
Secondary	Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline)		Baseline to Week 72
Secondary	Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline):		Baseline to Week 72
Secondary	Mean Change from Baseline in Visceral Adipose Tissue (VAT)		Baseline, Week 72
Secondary	Mean Change from Baseline in Waist Circumference at Umbilical Level		Baseline, Week 72
Secondary	Mean Change from Baseline in Systolic Blood Pressure (SBP)		Baseline, Week 72
Secondary	Mean Change from Baseline in non-High Density Lipoprotein (HDL)		Baseline, Week 72
Secondary	Mean Change from Baseline in HDL		Baseline, Week 72
Secondary	Mean Change from Baseline in Triglycerides		Baseline, Week 72
Secondary	Mean Change from Baseline in Fasting Glucose		Baseline, Week 72
Secondary	Mean Change from Baseline in Hemoglobin A1c (HbA1c)		Baseline, Week 72
Secondary	Mean Change from Baseline in High-sensitivity C-reactive Protein		Baseline, Week 72
Secondary	Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores		Baseline, Week 72
Secondary	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		Baseline, Week 72
Secondary	Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline)		Baseline to Week 72
Secondary	Pharmacokinetics (PK): Plasma Concentration of Orforglipron		Baseline to Week 72