A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

NCT06370728 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18621J2A-MC-GZPJ
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.

Conditions

Healthy

Keywords

Glucagon-Like Peptide (GLP)- 1

Outcome Measures

Primary Outcomes (3)

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

  PK: AUC (0-∞) of Orforglipron

  Predose up to Day 18

• PK: Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Orforglipron

  PK: AUC (0-tlast) of Orforglipron

  Predose up to Day 18

• PK: Maximum Observed Concentration (Cmax) of Orforglipron

  PK: Cmax of Orforglipron

  Predose up to Day 18

Study Arms (1)

Orforglipron + Carbamazepine

EXPERIMENTAL

Single dose of orforglipron along with twice-daily dose of carbamazepine administered orally

Drug: Orforglipron; Drug: Carbamazepine

Interventions

Orforglipron DRUG

Administered orally

Also known as: LY3502970

Orforglipron + Carbamazepine

Carbamazepine DRUG

Administered orally

Orforglipron + Carbamazepine

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).
• Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
• Have a hemoglobin level of
• at least 11.4 g/dL for individuals assigned female at birth (AFAB) and
• at least 12.5 g/dL for AMAB.
• Have venous access sufficient to allow for blood sampling.

You may not qualify if:

• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.
• Have an abnormal 12-lead electrocardiogram (ECG).
• Have human leucocyte antigen-B (HLA-B)\*1502 or HLA-A\*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.
• Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.
• Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

ICON Early Phase Services

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

orforglipron; Carbamazepine

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 17, 2024
• Study Start: May 6, 2024
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)