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
1 other identifier
interventional
48
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started Nov 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2025
CompletedStudy Start
First participant enrolled
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
December 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
May 19, 2026
May 1, 2026
11 months
November 19, 2025
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (15)
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
Study Arms (4)
ABBV-295 or Placebo-Group 1
EXPERIMENTALParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
ABBV-295 or Placebo-Group 2
EXPERIMENTALParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
ABBV-295 or Placebo-Group 3
EXPERIMENTALParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
ABBV-295 or Placebo-Group 4
EXPERIMENTALParticipants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (2)
CenExel ACT- Anaheim Clinical Trials /ID# 283200
Anaheim, California, 92801, United States
Acpru /Id# 278624
Grayslake, Illinois, 60030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
December 18, 2025
Study Start
November 19, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share