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NCT Number: NCT07291232

A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel ACT- Anaheim Clinical Trials /ID# 283200, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-295

Drug

Subcutaneous Injections

Placebo

Drug

Subcutaneous Injections

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 145 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.

  2. Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements

    Time frame: Up to approximately 145 days

    Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.

  3. Number of Participants with Change from Baseline in Electrocardiogram (ECG)

    Time frame: Up to approximately 145 days

    12-lead resting ECG will be recorded.

  4. Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed

    Time frame: Up to approximately 145 days

    Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.

  5. Maximum Observed Plasma Concentration (Cmax) of ABBV-295

    Time frame: Up to approximately 145 days

    Cmax of ABBV-295

  6. Time to Cmax (Tmax) of ABBV-295

    Time frame: Up to approximately 145 days

    Tmax of ABBV-295

  7. Trough plasma concentration (Ctrough) of ABBV-295

    Time frame: Up to approximately 145 days

    Ctrough of ABBV-295

  8. Apparent terminal phase elimination rate constant (BETA) of ABBV-295

    Time frame: Up to approximately 145 days

    BETA of ABBV-295

  9. Terminal phase elimination half-life (t1/2) of ABBV-295

    Time frame: Up to approximately 145 days

    t1/2 of ABBV-295

  10. Area under the plasma concentration-time curve (AUC) of ABBV-295

    Time frame: Up to approximately 145 days

    AUC of ABBV-295

  11. Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295

    Time frame: Up to approximately 145 days

    AUCtau of ABBV-295

  12. Dose Normalized Cmax of ABBV-295

    Time frame: Up to approximately 145 days

    Dose normalized Cmax of ABBV-295 will be assessed.

  13. Dose Normalized AUC of ABBV-295

    Time frame: Up to approximately 145 days

    Dose normalized AUC of ABBV-295 will be assessed.

  14. Incidence of Anti-Drug Antibodies (ADAs)

    Time frame: Up to approximately 145 days

    Incidence of ADAs will be assessed.

  15. Percent Change in Body Weight From Baseline

    Time frame: Up to approximately 145 days

    Percent change in body weight (kg) will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of Multiple Subcutaneous Doses of ABBV-295 in Adult Subjects With Obesity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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