A Study of ABBV-295 for Adults with Obesity
This study is looking at a new medication called ABBV-295, given as shots under the skin, for adults with obesity. Researchers want to see if ABBV-295 is safe and how your body handles it. Some participants will receive ABBV-295, while others will receive a placebo (an inactive substance that looks like the study drug). You might be able to join if you are between 18 and 65 years old and have a Body Mass Index (BMI) between 30.0 and 45.0. The study will measure side effects, changes in vital signs (like blood pressure), and heart activity (ECG) for up to about 145 days.
- Study design
- This is an interventional study involving 48 participants. It compares ABBV-295 to a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to approximately 145 days to monitor for side effects and changes in vital signs and ECG.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity
At a glance
Conditions
Where it's being run
2 sites across 2 statesStudy leadership
- ABBVIE INC. · STUDY_DIRECTOR · AbbVie
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Number of Participants with Adverse Events (AEs)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 MeasurementsUp 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)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 AssessedUp 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-295Up to approximately 194 days
Cmax of ABBV-295
- Time to Cmax (Tmax) of ABBV-295Up to approximately 194 days
Tmax of ABBV-295
- Trough plasma concentration (Ctrough) of ABBV-295Up to approximately 194 days
Ctrough of ABBV-295
- Apparent terminal phase elimination rate constant (BETA) of ABBV-295Up to approximately 194 days
BETA of ABBV-295
- Terminal phase elimination half-life (t1/2) of ABBV-295Up to approximately 194 days
t1/2 of ABBV-295
- Area under the plasma concentration-time curve (AUC) of ABBV-295Up to approximately 194 days
AUC of ABBV-295
- Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295Up to approximately 194 days
AUCtau of ABBV-295
- Dose Normalized Cmax of ABBV-295Up to approximately 194 days
Dose normalized Cmax of ABBV-295 will be assessed.
- Dose Normalized AUC of ABBV-295Up to approximately 194 days
Dose normalized AUC of ABBV-295 will be assessed.
- Incidence of Anti-Drug Antibodies (ADAs)Up to approximately 194 days
Incidence of ADAs will be assessed.
- Percent Change in Body Weight From BaselineUp to approximately 194 days
Percent change in body weight (kg) will be assessed.