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| ID | Type | Description | Link |
|---|---|---|---|
| J2A-MC-GZGJ | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3502970 Titration | Experimental | Dose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD, Participants were randomized to Fasted state or Fed state sequence on Day 22. |
|
| LY3502970 (Fasted/Fed) | Experimental | Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state. |
|
| LY3502970 (Fed/Fasted) | Experimental | Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3502970 | Drug | Administered Orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970. | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
| PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970 | PK: AUC0-24 of LY3502970. | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
| Time to Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
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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 |
|---|---|---|---|---|---|---|
| Lilly Centre for Clinical Pharmacology | Singapore | 138623 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38402332 | Derived | Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24. |
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During the titration period, participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Upon completion of the titration period, participants were randomized to Fasted state or Fed state sequence of Day 22.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2 Milligram (mg)/4 mg/8 mg LY3502970 | Dose Titration Period: Participants received increasing doses (2 mg, 4 mg, 8 mg) of LY3502970 administered orally every 7 days on Day 1 to Day 21. Participants were randomized to Fasted/Fed state sequence on Day 22. |
| FG001 | 16 mg LY3502970 (Fasted/Fed) | Test Period 1: Participants received 16 mg LY3502970 administered orally every day (QD), Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state. |
| FG002 | 16 mg LY3502970 (Fed/Fasted) | Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Titration Period |
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| Test Period 1 |
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| Test Period 2 |
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All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2 mg/4 mg/8/ mg LY3502970 | Dose Titration Period: Participants received increasing doses (2 mg, 4 mg, 8 mg) of LY3502970 administered orally every 7 days on Day 1 to Day 21. Participants were randomized to Fasted/Fed state sequence on Day 22. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970. | All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms per milliliter (ng/mL) | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
|
Baseline up to Day 49
All participants who are exposed to study intervention LY3502970. Participants will be analyzed according to the intervention they actually received.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 Milligram (mg) LY3502970 QD | 2 mg LY3502970 administered orally every day (QD), Day 1 to Day 8. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 8005955979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2021 | Mar 31, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2021 | Mar 31, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000729680 | orforglipron |
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| Received at Least One Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Primary | PK: Area Under the Concentration-time Curve From 0 to 24 Hour (AUC0-24) of LY3502970 | PK: AUC0-24 of LY3502970. | All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hour(h)/mL | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
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| Primary | Time to Maximum Observed Concentration (Tmax) of LY3502970 | PK: Tmax of LY3502970 | All participants who received LY3502970 in fed and fasted state and had evaluable PK samples, per protocol. | Posted | Median | Full Range | hour | PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) |
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|
| 0 |
| 33 |
| 0 |
| 33 |
| 27 |
| 33 |
| EG001 | 4 mg LY3502970 QD | 4 mg LY3502970 administered orally QD, Day 8 to Day 15 | 0 | 30 | 0 | 30 | 15 | 30 |
| EG002 | 8 mg LY3502970 QD | 8 mg LY3502970 administered orally QD, Day 15 to Day 22. | 0 | 30 | 0 | 30 | 13 | 30 |
| EG003 | 16 mg LY3502970 QD (Fasted) | 16 mg LY3502970 administered orally QD (fasted). | 0 | 28 | 0 | 28 | 18 | 28 |
| EG004 | 16 mg LY3502970 QD (Fed) | 16 mg LY3502970 administered orally QD (fed). | 0 | 27 | 0 | 27 | 12 | 27 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site bruise | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site phlebitis | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Catheter site infection | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Taste disorder | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
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