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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 4
- Primary Endpoint
- Number of Participants with Adverse Events (AEs)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 3 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 4 Extension
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 5
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 6
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 2
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 1
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 3
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: Placebo (Drug)
ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: ABBV-295 (Drug)
ABBV-295 or Placebo-Group 4
Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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.
Number of Participants with Adverse Events (AEs)
Time Frame: Up to approximately 145 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 145 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 145 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 145 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 145 days
Cmax of ABBV-295
Time to Cmax (Tmax) of ABBV-295
Time Frame: Up to approximately 145 days
Tmax of ABBV-295
Trough plasma concentration (Ctrough) of ABBV-295
Time Frame: Up to approximately 145 days
Ctrough of ABBV-295
Apparent terminal phase elimination rate constant (BETA) of ABBV-295
Time Frame: Up to approximately 145 days
BETA of ABBV-295
Terminal phase elimination half-life (t1/2) of ABBV-295
Time Frame: Up to approximately 145 days
t1/2 of ABBV-295
Dose Normalized Cmax of ABBV-295
Time Frame: Up to approximately 145 days
Dose normalized Cmax of ABBV-295 will be assessed.
Dose Normalized AUC of ABBV-295
Time Frame: Up to approximately 145 days
Dose normalized AUC of ABBV-295 will be assessed.
Incidence of Anti-Drug Antibodies (ADAs)
Time Frame: Up to approximately 145 days
Incidence of ADAs will be assessed.
Percent Change in Body Weight From Baseline
Time Frame: Up to approximately 145 days
Percent change in body weight (kg) will be assessed.
Area under the plasma concentration-time curve (AUC) of ABBV-295
Time Frame: Up to approximately 145 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 145 days
AUCtau of ABBV-295
Secondary Outcomes
No secondary outcomes reported