NCT05445232

Brief Summary

The main purpose of this study is to determine the effect of LY3437943 when administered subcutaneously on the levels of midazolam, warfarin and caffeine in the blood stream when administered orally as a drug cocktail in obese participants. This study will last up to approximately 25 weeks for each participant.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_1 obesity

Timeline
Completed

Started Jul 2022

Shorter than P25 for phase_1 obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

July 1, 2022

Last Update Submit

April 17, 2023

Conditions

Obesity

Keywords

OverweightObesityDrug InteractionCocktailPharmacokinetic

Outcome Measures

Primary Outcomes (6)

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

    PK: AUC\[0-∞\] of Midazolam

    Predose up to 24 hours postdose

  • PK: Maximum Observed Concentration (Cmax) of Midazolam

    PK: Cmax of Midazolam

    Predose up to 24 hours postdose

  • PK: AUC[0-∞] of Warfarin

    PK: AUC\[0-∞\] of Warfarin

    Predose up to 96 hours postdose

  • PK: Cmax of Warfarin

    PK: Cmax of Warfarin

    Predose up to 96 hours postdose

  • PK: AUC[0-∞] of Caffeine

    PK: AUC\[0-∞\] of Caffeine

    Predose up to 48 hours postdose

  • PK: Cmax of Caffeine

    PK: Cmax of Caffeine

    Predose up to 48 hours postdose

Study Arms (1)

LY3437943 + Drug Cocktail

EXPERIMENTAL

Midazolam in combination with warfarin and caffeine (drug cocktail) administered orally followed by LY3437943 administered subcutaneously (SC) in week 1. At weeks 8, 12, \& 16, the LY3437943 will be administered SC on Day 1 followed by midazolam in combination with warfarin and caffeine (drug cocktail) administered orally on Day 2.

Drug: LY3437943Drug: MidazolamDrug: WarfarinDrug: Caffeine

Interventions

LY3437943DRUG

Administered SC.

LY3437943 + Drug Cocktail
MidazolamDRUG

Administered orally.

LY3437943 + Drug Cocktail
WarfarinDRUG

Administered orally.

LY3437943 + Drug Cocktail
CaffeineDRUG

Administered orally.

LY3437943 + Drug Cocktail

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) within the range 27.0 to 40.0 kilograms per meter squared (kg/m²)
  • Male and female participants of childbearing potential who agree to use contraceptive methods

You may not qualify if:

  • Have a history of diabetes or current diagnosis of diabetes
  • History or presence of a of significant bleeding disorder
  • Participants with significant comorbidity
  • Participants receiving treatment with midazolam, warfarin, inhibitors or inducers of cytochrome P450 (CYP) -1A2, CYP2C9, or CYP3A4 enzymes, or drugs are CYP substrates and have a narrow therapeutic index

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Covance Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Covance Dallas

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

retatrutideMidazolamWarfarinCaffeine

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingXanthinesAlkaloidsPurinonesPurines

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
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

July 8, 2022

Primary Completion

February 24, 2023

Study Completion

February 24, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)