To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants

Phase 1

Active, not recruiting

• Conditions: Healthy
• Interventions: Drug: Retatrutide; Drug: Metoprolol

• Registration Number: NCT06808802
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The purpose of this study J1I-MC-GZQE is to measure the effect of retatrutide on the pharmacokinetics (PK) of metoprolol in healthy participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study Start: 2025-02-03
• Study First Posted: 2025-02-05
• Status Verified: 2025-03
• Primary Completion: 2025-04
• Study Completion: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and vital signs
• Have a body mass index (BMI) within the range 22.0 to 35.0 kilogram per square meter (kg/m2) (inclusive) at screening

Exclusion Criteria

• Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5% (48 millimole/mole (mmol/mol)
• Have a mean supine screening pulse rate of less than 45 or greater than 100 beats per minute (bpm) from 2 assessments. If a repeat measurement (mean of 2 assessments) shows values within the range of 45 to 100 bpm, the participant may be included in the trial
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data
• Had any of the following cardiovascular conditions prior to screening: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalization due to congestive heart failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Retatrutide	Metoprolol	In period 1, participants will be administered a singe oral dose of metoprolol followed by a 1-week washout before retatrutide subcutaneous (SC) injection is given in period 2, followed by a second dose of metoprolol.
Retatrutide	Retatrutide	In period 1, participants will be administered a singe oral dose of metoprolol followed by a 1-week washout before retatrutide subcutaneous (SC) injection is given in period 2, followed by a second dose of metoprolol.

Primary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of Metoprolol	Day 1 to Day 3	PK: Cmax of Metoprolol
PK: Cmax of Metoprolol with Retatrutide	Day 9 to Day 11	PK: Cmax of Metoprolol with Retatrutide
Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol	Day 1 to Day 3	PK: AUC (0-∞) of Metoprolol
Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide	Day 9 to Day 11	PK: AUC (0-∞) of Metoprolol with Retatrutide

Secondary Outcome Measures

Name	Time	Method
Number of Participants with an Incidence of Treatment Emergent Adverse Events TEAEs (TEAEs)	Baseline to Day 44

Trial Locations

Locations (1)

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore