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

NCT06808802 | Completed Phase 1

• 2 other identifiers: 27303J1I-MC-GZQE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics (PK): Area Under Concentration From Time Zero to Infinity (AUC[0-∞]) of Metoprolol

  PK: AUC (0-∞) of Metoprolol

  Day 1 to Day 3

• Pharmacokinetics (PK): AUC (0-∞) of Metoprolol with Retatrutide

  PK: AUC (0-∞) of Metoprolol with Retatrutide

  Day 9 to Day 11

• PK: Maximum Concentration (Cmax) of Metoprolol

  PK: Cmax of Metoprolol

  Day 1 to Day 3

• PK: Cmax of Metoprolol with Retatrutide

  PK: Cmax of Metoprolol with Retatrutide

  Day 9 to Day 11

Secondary Outcomes (1)

• Number of Participants with an Incidence of Treatment Emergent Adverse Events TEAEs (TEAEs)

  Baseline to Day 44

Study Arms (1)

Retatrutide

EXPERIMENTAL

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.

Drug: Retatrutide; Drug: Metoprolol

Interventions

Retatrutide DRUG

Administered subcutaneously (SC)

Also known as: LY3437943

Retatrutide

Metoprolol DRUG

Administered orally

Retatrutide

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

retatrutide; Metoprolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 5, 2025
• Study Start: February 3, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)