Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07291232 | A Study of ABBV-295 Subcutaneous Injections to Assess Adverse Events and Pharmacokinetics in Adult Participants With Obesity | PHASE1 | RECRUITING | 48 | — | — | Nov 19, 2025 | Oct 1, 2026 | May 19, 2026 | 2 | United States |
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 like heart rate, systolic and diastolic blood pressure will be assessed.
12-lead resting ECG will be recorded.
Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed.
Cmax of ABBV-295
Tmax of ABBV-295
Ctrough of ABBV-295
BETA of ABBV-295
t1/2 of ABBV-295
AUC of ABBV-295
AUCtau of ABBV-295
Dose normalized Cmax of ABBV-295 will be assessed.
Dose normalized AUC of ABBV-295 will be assessed.
Incidence of ADAs will be assessed.
Percent change in body weight (kg) will be assessed.
| Arm | Type | Description |
|---|---|---|
| ABBV-295 or Placebo-Group 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 3 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 4 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-295 | DRUG | Subcutaneous Injections |
| Placebo | DRUG | Subcutaneous Injections |
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, c...