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

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: Obesity
• Intervention / Treatment: Drug: ABBV-295; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

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

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

How is the study designed?

Design Details

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

Number of Arms

4

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 145 days
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements	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 145 days
Number of Participants with Change from Baseline in Electrocardiogram (ECG)	12-lead resting ECG will be recorded.	Up to approximately 145 days
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed	Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.	Up to approximately 145 days
Maximum Observed Plasma Concentration (Cmax) of ABBV-295	Cmax of ABBV-295	Up to approximately 145 days
Time to Cmax (Tmax) of ABBV-295	Tmax of ABBV-295	Up to approximately 145 days
Trough plasma concentration (Ctrough) of ABBV-295	Ctrough of ABBV-295	Up to approximately 145 days
Apparent terminal phase elimination rate constant (BETA) of ABBV-295	BETA of ABBV-295	Up to approximately 145 days
Terminal phase elimination half-life (t1/2) of ABBV-295	t1/2 of ABBV-295	Up to approximately 145 days
Area under the plasma concentration-time curve (AUC) of ABBV-295	AUC of ABBV-295	Up to approximately 145 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295	AUCtau of ABBV-295	Up to approximately 145 days
Dose Normalized Cmax of ABBV-295	Dose normalized Cmax of ABBV-295 will be assessed.	Up to approximately 145 days
Dose Normalized AUC of ABBV-295	Dose normalized AUC of ABBV-295 will be assessed.	Up to approximately 145 days
Incidence of Anti-Drug Antibodies (ADAs)	Incidence of ADAs will be assessed.	Up to approximately 145 days
Percent Change in Body Weight From Baseline	Percent change in body weight (kg) will be assessed.	Up to approximately 145 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

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): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Obesity; ABBV-295
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• 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