NCT07013643

A Study to Investigate the Effect of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on Pharmacokinetics of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

An Open-label, Single-sequence Multiple Cohort Study to Assess the Effect of Multiple Doses of AZD6234, AZD9550, and a Combination of AZD9550 and AZD6234 on the Pharmacokinetics of Single Doses of Combined Oral Contraceptive Ethinyl Estradiol/Levonorgestrel in Healthy Female Participants Living With Overweight or Obesity

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study will measure the effects of multiple doses of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 given as injection(s) on pharmacokinetics (PK) of combined oral contraceptive (CoC) ethinyl estradiol (EE)/levonorgestrel (LEVO) in healthy female participants with obesity.

Detailed description

This is a Phase I, open-label, single-sequence, multiple-cohort study which will be performed at multiple study sites in healthy females of childbearing and non-childbearing potential. The purpose of this study is to investigate the effect of AZD6234, AZD9550 and a combination of AZD9550 and AZD6234 on the PK, safety and tolerability of a CoC, ethinyl estradiol/levonorgestrel (EE/LEVO). The study will have 3 cohorts, and each cohort will consist of 5 periods which include, Screening, Start, Up-titration, Maintenance, and Follow-up periods.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	AZD6234	AZD6234 will be administered as a subcutaneous injection in the abdomen.
DRUG	Ethinyl estradiol/Levonorgestrel (EE/LEVO)	EE/LEVO will be administered as combined oral tablets.
DRUG	Acetaminophen (APAP)	APAP will be administered orally as a solution.
DRUG	AZD9550	AZD9550 will be administered as a subcutaneous injection in the abdomen.

Timeline

• Start date: 2025-06-04
• Primary completion: 2026-12-25
• Completion: 2026-12-25
• First posted: 2025-06-10
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study