Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-295
Brief 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.
Interventions
DRUGABBV-295
Subcutaneous Injections
Oral Tablet
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to approximately 128 days | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed