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

NCT07414784 | Active Not Recruiting Phase 1

• 1 other identifier: M26-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-295

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  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.

  Up to approximately 128 days

Study Arms (1)

ABBV-295 with Levonorgestrel and Ethinyl Estradiol

EXPERIMENTAL

Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days.

Drug: ABBV-295; Drug: Levonorgestrel/Ethinyl Estradiol

Interventions

ABBV-295 DRUG

Subcutaneous Injections

ABBV-295 with Levonorgestrel and Ethinyl Estradiol

Levonorgestrel/Ethinyl Estradiol DRUG

Oral Tablet

ABBV-295 with Levonorgestrel and Ethinyl Estradiol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (2)

CenExel ACT- Anaheim Clinical Trials /ID# 281863

Anaheim, California, 92801, United States

Location

Acpru /Id# 280538

Grayslake, Illinois, 60030, United States

Location

MeSH Terms

Interventions

Ethinyl Estradiol-Norgestrel Combination

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 17, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)