LivingGLP1
Study S002049

A Phase 1 Multiple Dose Study to Investigate the Pharmacokinetics, Safety, and Tolerability of LY3502970 in Fed and Fasted Healthy Participants

ClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT05110794
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
34
Start
2021-11-05
Primary completion
2022-02-10
Lead sponsor
Eli Lilly and Company
Conditions
Healthy
Interventions
DRUG:LY3502970
Results posted
TRUE
Individual participant data sharing
NO
Secondary identifiers
OTHER:J2A-MC-GZGJ

Registered primary outcomes

  • PK: Maximum Observed Concentration (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: 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: 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)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0004741Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist.
Ma X, Diabetes therapy : research, treatment and education of diabetes and related disorders
2024Randomized trialPMID 38402332DOIcites ClinicalTrials.gov:NCT05110794; registry reference DERIVED:38402332