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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZPI | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated.
The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron | Experimental | Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels. |
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| Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron | Experimental | Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orforglipron | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Pharmacokinetics (PK): Steady-state area under the concentration versus time curve from time 0 to Ï„ hour time point AUC(0-Ï„) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths | Ï„ is 24 hours for once daily (QD) dosing | Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) |
| Part B: PK: Steady-state Maximum Observed Concentration (Cmax) of Orforglipron capsule at test dose levels 2,3,4 and 6 along with the corresponding tablet dose strengths | Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: PK: Steady-state AUC(0-Ï„) of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths | Ï„ is 24 hours for QD dosing | Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) |
| Part B: PK: Steady-state Cmax of Orforglipron capsule at test dose levels 1 and 5 along with the corresponding tablet dose strengths |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States | ||
| Collaborative Neuroscience Research, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41994902 | Derived | Ma X, Li YG, Raha S, Sperry DC, Coutant DE, Bhattachar S. Pharmacokinetic Bioequivalence of Orforglipron Tablets and Capsules in Healthy Participants With Obesity or Overweight. Diabetes Obes Metab. 2026 Jul;28(7):5803-5809. doi: 10.1111/dom.70783. Epub 2026 Apr 17. |
| Label | URL |
|---|---|
| A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2026 | |
| Reset | May 26, 2026 |
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|
| Day 1 up to Week 9 (Cohort 1), Week 15 (Cohort 2) |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Fortrea Clinical Research Unit | Daytona Beach | Florida | 32117 | United States |
| Altasciences Company Inc. | Overland Park | Kansas | 66212 | United States |
| QPS | Springfield | Missouri | 65802 | United States |
| Fortrea Clinical Research Unit | Dallas | Texas | 75247 | United States |
| Fortrea Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2026 | May 26, 2026 | |||
| Jun 20, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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