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Active not recruitingPhase 1

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

A Phase 1 Drug-Drug Interaction Study of ABBV-295, Levonorgestrel, and Ethinyl Estradiol in Healthy Adult Female Subjects With Overweight or Obesity

Lead sponsor

AbbVie

Asset

ABBV-295

Subcutaneous · Amylin analog

Listed sites

2

Recruiting sites

Enrollment

20

actual

Study population

Key I/E criteria

BMI 25-35Female

Primary endpoint

Adverse Events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07414784
Org study IDM26-006

Timeline

Milestones

Study start2026-02-11actual
Study first posted2026-02-17actual
Last update posted2026-04-27actual
Primary completion2026-07estimated (month precision)
Study completion2026-07estimated (month precision)

Assets

Investigational agents

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexFemale
Healthy volunteersAccepted

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.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:Up to approximately 128 days

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.