A Study of ABBV-295 Subcutaneous Injections to Assess Pharmacokinetics and Adverse Events in Healthy Adult Women Participants With Overweight or Obesity Taking Oral Contraceptives

Study Identifier
M26-006
CT.gov Identifier
NCT07414784
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Healthy Volunteer
    • Study Drug
  • ABBV-295
  • Levonorgestrel/Ethinyl Estradiol
    • Phase
    Phase 1
    Sex
    Female
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * BMI ≥ 25.0 to ≤ 35.0 kg/m2 after rounding to the tenths decimal at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) * A female who is not pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study or for approximately 60 days after the last dose of study treatment.
    Exclusion Criteria:
    * Participant has a self-reported change in body weight ≥ 5% within 3 months prior to Screening. * HbA1c ≥ 6.5% and/or serum glucose ≥ 126 mg/dL at Screening. * Participant has taken a medication for the purpose of treating obesity or has been enrolled in an obesity trial within 90 days prior to study treatment administration.

    Protocol Summary

    This Study of ABBV-295 subcutaneous injections will assess pharmacokinetics and adverse events in healthy adult women participants with overweight or obesity taking oral contraceptives.

    Study Locations

    Location
    Status
    Location
    CenExel ACT- Anaheim Clinical Trials /ID# 281863
    Anaheim, California, United States, 92801
    Status
    Not applicable
    Location
    Acpru /Id# 280538
    Grayslake, Illinois, United States, 60030
    Status
    Not applicable