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

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT07013643
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Participants

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 4, 2025
Status verified
May 2026
Primary completion
Dec 25, 2026
Completion
Dec 25, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort-1 AZD6234 + EE/LEVO + Acetaminophen (APAP)
    All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 administration.
  • Experimental: Cohort-2: AZD6234+AZD9550+EE/LEVO+APAP
    All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD6234 and AZD9550 administration.
  • Experimental: Cohort-3 AZD9550 + EE/LEVO + APAP
    All participants will receive CoC (EE/LEVO) and separately, APAP, treatments throughout the study during the up-titration and maintenance periods of subcutaneous AZD9550 administration.

Primary Outcome Measure

Area under the concentration-time curve from time 0 to infinity (AUCinf) of EE and LEVO [ Time Frame: Cohort 1: At predefined intervals from Day -5 up to Day 99; Cohort 2 : At pre-defined interval from Day -5 up to Day 169; Cohort 3: At predefined intervals from Day -5 up to Day 272 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Brooklyn, MD

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