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

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Final enrollment: 100 participants (planned 50)
    • Site details revised at 2 of 2 sites
  2. Primary endpoints: details revised at 1 of 5 entries
    • Interventions: AZD6234 (Drug), AZD9550 (Drug), Acetaminophen (APAP) (Drug), Ethinyl estradiol/Levonorgestrel (EE/LEVO) (Drug) to AZD6234 (Drug), AZD9550 (Drug), Acetaminophen (APAP) (Drug), Ethinyl estradiol/Levonorgestrel (EE/LEVO) (Drug)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 11 entries
  3. 2 versions Re-verified since Jul 17, 2026, no change to tracked fieldsv10-v11
  4. Primary and study completion pushed from Dec 25, 2026 to Jul 9, 2027v9 Show 4 more changesShow less
    • Trial arms changed: 3 → 4
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: details revised at 5 of 11 entries
    • Study description revised
  5. Re-verified, no change to tracked fieldsv8
  6. Enrollment reduced: 75 → 50 participantsv7
  7. Enrollment target: 50 to 75v6 Show 5 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 8 to 11
    • Study arms: 2 to 3
    • Study description shortened, about 1 word
    • Study title expanded, about 1 word
  8. Primary and study completion dates: Jul 20, 2026 to Dec 25, 2026v5
  9. Primary and study completion dates: Jan 7, 2026 to Jul 20, 2026v4
  10. Enrollment target: 25 to 50v3 Show 8 more changesShow less
    • Primary endpoints: 8 to 5
    • Interventions: AZD6234 (Drug), Acetaminophen (APAP) (Drug), Ethinyl estradiol/Levonorgestrel (EE/LEVO) (Drug) to AZD6234 (Drug), AZD9550 (Drug), Acetaminophen (APAP) (Drug), Ethinyl estradiol/Levonorgestrel (EE/LEVO) (Drug)
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: 2 to 8
    • Site details revised at 1 of 2 sites
    • Study title expanded, about 10 words
    • Study arms: 1 to 2
    • Study description expanded, about 1 word
  11. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v2
  12. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AstraZeneca
729 trials monitored
See 62 trials at risk
Obesity
3,888 trials monitored
See 157 trials at risk
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.
Trial Details
NCT Number NCT07013643
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Healthy Participants
Related terms Obesity, Overweight
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov