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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-JE-GZPD | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orforglipron Dose 1 | Experimental | Participants will receive orforglipron orally. |
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| Orforglipron Dose 2 | Experimental | Participants will receive orforglipron orally. |
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| Orforglipron Dose 3 | Experimental | Participants will receive orforglipron orally. |
|
| Placebo | Placebo Comparator | Participants will receive placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change in Body Weight | Baseline, Week 72 | |
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Baseline to Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline to Week 72 | |
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction | Baseline to Week 72 | |
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Inclusion Criteria:
Exclusion Criteria:
For participants with Type 2 Diabetes (T2D):
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.
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nishiyamadou Keiwa Hospital | Naka | Ibaraki | 311-0133 | Japan | ||
| Tsuchiura Beryl Clinic |
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.
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.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 18, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009748 | Nutrition Disorders |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| Placebo | Drug | Administered orally |
|
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction |
| Baseline to Week 72 |
| Mean Change from Baseline in Body Mass Index (BMI) | Baseline, Week 72 |
| Percentage of Participants Who Had Improvements in Hypertension | Baseline to Week 72 |
| Percentage of Participants Who Had Improvements in Dyslipidemia (only for participants with Dyslipidemia at baseline) | Baseline to Week 72 |
| Percentage of Participants Who Achieve HbA1c Target value (<6.5% (48 mmol/mol) at Week 72 (only T2D at Baseline): | Baseline to Week 72 |
| Mean Change from Baseline in Visceral Adipose Tissue (VAT) | Baseline, Week 72 |
| Mean Change from Baseline in Waist Circumference at Umbilical Level | Baseline, Week 72 |
| Mean Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 72 |
| Mean Change from Baseline in non-High Density Lipoprotein (HDL) | Baseline, Week 72 |
| Mean Change from Baseline in HDL | Baseline, Week 72 |
| Mean Change from Baseline in Triglycerides | Baseline, Week 72 |
| Mean Change from Baseline in Fasting Glucose | Baseline, Week 72 |
| Mean Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 72 |
| Mean Change from Baseline in High-sensitivity C-reactive Protein | Baseline, Week 72 |
| Mean Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores | Baseline, Week 72 |
| 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 |
| Time to Onset of Type 2 Diabetes (T2D) (only non T2D at Baseline) | Baseline to Week 72 |
| Pharmacokinetics (PK): Plasma Concentration of Orforglipron | Baseline to Week 72 |
| Tsuchiura |
| Ibaraki |
| 300-0062 |
| Japan |
| Ohishi Internal Medicine Clinic | Tsuchiura | Ibaraki | 300-0835 | Japan |
| Shonan Takai Clinic | Kamakura | Kanagawa | 247-0055 | Japan |
| Takai Internal Medicine Clinic | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Medical Corporation Yuga Higashirinkan Kaneshiro Diabetes Clinic | Sagamihara | Kanagawa | 252-0302 | Japan |
| Shiraiwa Medical Clinic | Kashihara | Osaka | 582-0005 | Japan |
| Medical Corporation Heishinkai OCROM Clinic | Suita-shi | Osaka | 565-0853 | Japan |
| Sugiura Clinic | Kawaguchi | Saitama | 332-0012 | Japan |
| Yotsuya Medical Cube | Chiyoda City | Tokyo | 102-0084 | Japan |
| Nihonbashi Sakura Clinic | Chuo-ku | Tokyo | 103-0025 | Japan |
| Tokyo-Eki Center-building Clinic | Chuo-ku | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic | Chuo-ku | Tokyo | 104-0031 | Japan |
| Heishinkai Medical Group ToCROM Clinic | Shinjuku-ku | Tokyo | 160-0008 | Japan |
| Hiroshima Station Clinic | Hiroshima | 732-0053 | Japan |
| Osaka Nishiumeda Clinic | Osaka | 530-0001 | Japan |
| D013568 |
| Pathological Conditions, Signs and Symptoms |