NCT07291232 · AbbVie
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
What this study is about
This study is to assess side effects, change in body weight and how the drug moves through the body in adult participants with obesity receiving ABBV-295 injected under the skin injections or matching placebo.
View original scientific description
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.
Interventions
DRUG
ABBV-295
Subcutaneous Injections
DRUG
Placebo
Subcutaneous Injections
Primary outcome measures
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.
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.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to approximately 194 days
12-lead resting ECG will be recorded.
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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-295
Time frame: Up to approximately 194 days
Cmax of ABBV-295
Time to Cmax (Tmax) of ABBV-295
Time frame: Up to approximately 194 days
Tmax of ABBV-295
Trough plasma concentration (Ctrough) of ABBV-295
Time frame: Up to approximately 194 days
Ctrough of ABBV-295
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Time frame: Up to approximately 194 days
BETA of ABBV-295
Terminal phase elimination half-life (t1/2) of ABBV-295
Time frame: Up to approximately 194 days
t1/2 of ABBV-295
Area under the plasma concentration-time curve (AUC) of ABBV-295
Time frame: Up to approximately 194 days
AUC of ABBV-295
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
Dose Normalized Cmax of ABBV-295
Time frame: Up to approximately 194 days
Dose normalized Cmax of ABBV-295 will be assessed.
Dose Normalized AUC of ABBV-295
Time frame: Up to approximately 194 days
Dose normalized AUC of ABBV-295 will be assessed.
Incidence of Anti-Drug Antibodies (ADAs)
Time frame: Up to approximately 194 days
Incidence of ADAs will be assessed.
Percent Change in Body Weight From Baseline
Time frame: Up to approximately 194 days
Percent change in body weight (kg) will be assessed.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Anaheim, California
- Grayslake, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2026 · Source of record for eligibility and locations