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

August 5, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • CenExel Act- Anaheim Clinical Trials /ID# 283200
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 278624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections
Experimental: ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Drug: ABBV-295
Subcutaneous Injections
Drug: Placebo
Subcutaneous Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 194 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.
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 abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed.
Up to approximately 194 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Time Frame: Up to approximately 194 days
12-lead resting ECG will be recorded.
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
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.
Up to approximately 194 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
Time Frame: Up to approximately 194 days
Cmax of ABBV-295
Up to approximately 194 days
Time to Cmax (Tmax) of ABBV-295
Time Frame: Up to approximately 194 days
Tmax of ABBV-295
Up to approximately 194 days
Trough plasma concentration (Ctrough) of ABBV-295
Time Frame: Up to approximately 194 days
Ctrough of ABBV-295
Up to approximately 194 days
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Time Frame: Up to approximately 194 days
BETA of ABBV-295
Up to approximately 194 days
Terminal phase elimination half-life (t1/2) of ABBV-295
Time Frame: Up to approximately 194 days
t1/2 of ABBV-295
Up to approximately 194 days
Area under the plasma concentration-time curve (AUC) of ABBV-295
Time Frame: Up to approximately 194 days
AUC of ABBV-295
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
AUCtau of ABBV-295
Up to approximately 194 days
Dose Normalized Cmax of ABBV-295
Time Frame: Up to approximately 194 days
Dose normalized Cmax of ABBV-295 will be assessed.
Up to approximately 194 days
Dose Normalized AUC of ABBV-295
Time Frame: Up to approximately 194 days
Dose normalized AUC of ABBV-295 will be assessed.
Up to approximately 194 days
Incidence of Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 194 days
Incidence of ADAs will be assessed.
Up to approximately 194 days
Percent Change in Body Weight From Baseline
Time Frame: Up to approximately 194 days
Percent change in body weight (kg) will be assessed.
Up to approximately 194 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M26-089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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