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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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