← Trials/Trial dossier/NCT05051566
A Multiple Dose Study of LY3502970 in Healthy Participants
A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Lead sponsor
Asset
Orforglipron
Oral · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
26
actual
Study population
Healthy volunteers
Key I/E criteria
•BMI 18.5-35•Healthy volunteers
Primary endpoints
•Part•Part B•Cmax of LY3502970
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
9 endpointsPart A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanograms per milliliter (ng/mL) | 95% CI |
|---|---|---|
| Part A (LY3502970)16 mg reference capsule (Day 24) | 66.2 | — |
| 16 mg prototype 1 tablet (Days 30 and 36) | 111 | — |
| 16 mg prototype 2 tablet (Days 30 and 36) | 97.4 | — |
Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), nanogram*hours per milliliter (ng*h/mL) | 95% CI |
|---|---|---|
| Part A (LY3502970)16 mg reference capsule (Day 24) | 988 | — |
| 16 mg prototype 1 tablet (Days 30 and 36) | 1480 | — |
| 16 mg prototype 2 tablet (Days 30 and 36) | 1400 | — |
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (median), hours | 95% CI |
|---|---|---|
| Part A (LY3502970)16 mg reference capsule (Day 24) | 7.02 | 4 – 8 |
| 16 mg prototype 1 tablet (Days 30 and 36) | 8 | 4 – 16 |
| 16 mg prototype 2 tablet (Days 30 and 36) | 8 | 4 – 16 |
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng/mL | 95% CI |
|---|---|---|
| Part B16 mg prototype 2 tablet (Fasted) (Day 24) | 63.4 | — |
| 16 mg prototype 2 tablet (Fed) (Day 30) | 56.3 | — |
| 16 mg Prototype 2 tablet + PPI (Fasted) (Day 36) | 59.6 | — |
Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), ng*h/mL | 95% CI |
|---|---|---|
| Part B16 mg prototype 2 tablet (Fasted) (Day 24) | 903 | — |
| 16 mg prototype 2 tablet (Fed) (Day 30) | 865 | — |
| 16 mg Prototype 2 tablet + PPI (Fasted) (Day 36) | 956 | — |
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation
Time frame:Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
concentration, descriptive
Posted result
| Group | Value (median), hours | 95% CI |
|---|---|---|
| Part B16 mg prototype 2 tablet (Fasted) (Day 24) | 8.00 | 4.00 – 12.00 |
| 16 mg prototype 2 tablet (Fed) (Day 30) | 7.00 | 2.00 – 16.05 |
| 16 mg Prototype 2 tablet + PPI (Fasted) (Day 36) | 7.00 | 4.00 – 12.00 |
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Time frame:Predose up to 24 hours postdose
Cmax
concentration, descriptive
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970
Time frame:Predose up to 24 hours postdose
AUC₀–∞
concentration, descriptive
PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
Time frame:Predose up to 24 hours postdose
Tmax
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.