A Phase 1, Open-Label, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity

Registration

Registration

NCT06916065

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

188

Start

2025-04-09

Primary completion

2026-01-19

Lead sponsor

Eli Lilly and Company

Conditions

Overweight; Obesity

Interventions

DRUG:Eloralintide and Tirzepatide; DRUG:Eloralintide

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

OTHER:J3R-MC-YDAE

Registered primary outcomes

• Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide [Day 106 Predose to Approximately Week 26]
• Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide [Day 106 Predose to Approximately Week 26]
• Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide [Baseline Up to Approximately Week 11]
• Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide [Baseline Up to Approximately Week 11]
• Cohorts E and F: PK: AUC of Eloralintide [Day 8 Predose Up to Approximately Week 12]
• Cohorts E and F: PK: Cmax of Eloralintide [Day 8 Predose Up to Approximately Week 12]
• Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline Up to Approximately Week 26]