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Orforglipron and Carbamazepine Interaction in Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to day 18
Awards & highlights

Summary

This trial aims to see how carbamazepine affects the levels of orforglipron in the blood and how long it stays in the body when taken by mouth in healthy individuals. It will

Who is the study for?
This clinical trial is for healthy individuals who are interested in helping to understand how the body processes a new drug, Orforglipron, when taken with an existing medication, Carbamazepine. The study will last about 77 days per participant.
What is being tested?
The study aims to assess the impact of Carbamazepine on the levels and elimination of Orforglipron from the body when both drugs are taken orally by healthy participants. It also looks at their safety and tolerability when used separately or together.
What are the potential side effects?
Possible side effects may include reactions typical of taking oral medications such as digestive discomfort, potential allergic reactions, or other unspecified drug-related adverse events.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to day 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to day 18 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron
PK: Maximum Observed Concentration (Cmax) of Orforglipron
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-∞]) of Orforglipron

Trial Design

1Treatment groups
Experimental Treatment
Group I: Orforglipron + CarbamazepineExperimental Treatment2 Interventions
Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbamazepine
2016
Completed Phase 4
~2690

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,218,080 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
416,446 Total Patients Enrolled
~20 spots leftby Sep 2025
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