DRUG
LY3437943
Administered SC.
A Drug-Drug Interaction (DDI) Study of LY3437943 in Obese Participants
Status
Completed
Phase
Phase 1
Enrollment
32
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Midazolam
Administered orally.
DRUG
Warfarin
Administered orally.
DRUG
Caffeine
Administered orally.
Timeline
From registration to results.
First posted
Jul 6, 2022
Study start
Jul 8, 2022
Primary completion
Feb 24, 2023
Study completion
Feb 24, 2023
Results posted
Not reported
Registry updated
Apr 18, 2023
Outcomes
What the study measures.
Primary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Midazolam
Time frame · Predose up to 24 hours postdose
PK: AUC\[0-∞\] of Midazolam
PK: Maximum Observed Concentration (Cmax) of Midazolam
Time frame · Predose up to 24 hours postdose
PK: Cmax of Midazolam
PK: AUC[0-∞] of Warfarin
Time frame · Predose up to 96 hours postdose
PK: AUC\[0-∞\] of Warfarin
PK: Cmax of Warfarin
Time frame · Predose up to 96 hours postdose
PK: Cmax of Warfarin
PK: AUC[0-∞] of Caffeine
Time frame · Predose up to 48 hours postdose
PK: AUC\[0-∞\] of Caffeine
PK: Cmax of Caffeine
Time frame · Predose up to 48 hours postdose
PK: Cmax of Caffeine
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Covance Clinical Research Unit
Daytona Beach, Florida, United States
Covance Dallas
Dallas, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Retatrutide.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.