Obesity
Conditions
Keywords
Obesity, ABBV-295
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.
Interventions
DRUGABBV-295
Subcutaneous Injections
DRUGPlacebo
Subcutaneous Injections
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Measurements | 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) | 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 | 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 | Up to approximately 194 days | Cmax of ABBV-295 |
| Time to Cmax (Tmax) of ABBV-295 | Up to approximately 194 days | Tmax of ABBV-295 |
| Trough plasma concentration (Ctrough) of ABBV-295 | Up to approximately 194 days | Ctrough of ABBV-295 |
| Apparent terminal phase elimination rate constant (BETA) of ABBV-295 | Up to approximately 194 days | BETA of ABBV-295 |
| Terminal phase elimination half-life (t1/2) of ABBV-295 | Up to approximately 194 days | t1/2 of ABBV-295 |
| Area under the plasma concentration-time curve (AUC) of ABBV-295 | Up to approximately 194 days | AUC of ABBV-295 |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295 | Up to approximately 194 days | AUCtau of ABBV-295 |
| Dose Normalized Cmax of ABBV-295 | Up to approximately 194 days | Dose normalized Cmax of ABBV-295 will be assessed. |
| Dose Normalized AUC of ABBV-295 | Up 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 Baseline | Up to approximately 194 days | Percent change in body weight (kg) will be assessed. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed