Recruiting
Phase 1

ABBV-295

Sponsor:

AbbVie

Code:

NCT07291232

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ABBV-295

Placebo

Study Details

Brief summary:

This study is to assess adverse events, change in body weight and pharmacokinetics in adult participants with obesity receiving ABBV-295 subcutaneous injections or matching placebo.

Conditions

Obesity

Study ID

NCT07291232

Start date

Nov 19, 2025

Status verified date

Aug, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • BMI ≥ 30.0 to ≤ 45.0 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) with or without weight related stable comorbidities (e.g., hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
  • 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 180 days prior to study treatment administration.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABBV-295 or Placebo-Group 1

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

experimental: ABBV-295 or Placebo-Group 2

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

experimental: ABBV-295 or Placebo-Group 3

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

experimental: ABBV-295 or Placebo-Group 3 Extension

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.

experimental: ABBV-295 or Placebo-Group 4

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.

experimental: ABBV-295 or Placebo-Group 4 Extension

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.

experimental: ABBV-295 or Placebo-Group 5

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.

experimental: ABBV-295 or Placebo-Group 6

Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.

Interventions

ABBV-295

Subcutaneous Injections

Placebo

Subcutaneous Injections

Primary outcome measure

  • Number of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 194 days ]
  • Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements [ Time Frame: Up to approximately 194 days ]
  • Number of Participants with Change from Baseline in Electrocardiogram (ECG) [ Time Frame: Up to approximately 194 days ]
  • Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed [ Time Frame: Up to approximately 194 days ]
  • Maximum Observed Plasma Concentration (Cmax) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Time to Cmax (Tmax) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Trough plasma concentration (Ctrough) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Apparent terminal phase elimination rate constant (BETA) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Terminal phase elimination half-life (t1/2) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Area under the plasma concentration-time curve (AUC) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Dose Normalized Cmax of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Dose Normalized AUC of ABBV-295 [ Time Frame: Up to approximately 194 days ]
  • Incidence of Anti-Drug Antibodies (ADAs) [ Time Frame: Up to approximately 194 days ]
  • Percent Change in Body Weight From Baseline [ Time Frame: Up to approximately 194 days ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

CenExel Act- Anaheim Clinical Trials /ID# 283200

Recruiting

Anaheim, California, United States, 92801

Acpru /Id# 278624

Recruiting

Grayslake, Illinois, United States, 60030

More Information

Sponsor

AbbVie

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Obesity
  • ABBV-295

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AbbVie on 2026-08-07.