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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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