Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-295 · 2 trials · 2 indications
The primary efficacy endpoint is the percent change from baseline in body weight. This measure assesses the effect of various doses of ABBV-295 compared to placebo on reducing body weight in subjects with obesity or overweight with weight-related comorbidities.
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 Arm 1 | EXPERIMENTAL | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| ABBV-295 Arm 2 | EXPERIMENTAL | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| ABBV-295 Arm 3 | EXPERIMENTAL | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| ABBV-295 Arm 4 | EXPERIMENTAL | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| ABBV-295 Arm 5 | EXPERIMENTAL | Participants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| ABBV-295 Arm 6 | EXPERIMENTAL | Particpants will have their doses escalated up to a maintenance dose during the Double-Blind Period. |
| Placebo | PLACEBO_COMPARATOR | Participants will follow the same dosing schedule as active treatment arms during the Double-Blind Period. |
| 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 3 Extension | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
| ABBV-295 or Placebo-Group 4 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
| ABBV-295 or Placebo-Group 4 Extension | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks or 20 weeks. |
| ABBV-295 or Placebo-Group 5 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
| ABBV-295 or Placebo-Group 6 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 20 weeks. |
| Name | Type | Description |
|---|---|---|
| ABBV-295 | DRUG | Subcutaneous |
| Placebo | DRUG | Subcutaneous |
Inclusion Criteria: * BMI ≥ 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) OR * BMI ≥ 27.0 to \< 30.0 kg/m2 at Screening (BMI is calculated as weight in kg divided by the square of height measured in meters) with at least one of the fo...
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ABBV-295 is an investigational small molecule being studied for the treatment of obesity and overweight with weight-related comorbidities. It is in Phase 2 clinical development and has not been approved for any indication. AbbVie is evaluating it in adults aged 18 years and older.
ABBV-295 targets amylin, a hormone involved in appetite regulation and satiety. By acting on amylin, the drug is designed to reduce food intake and support weight loss. It is a small molecule rather than a peptide or antibody, which distinguishes it from other amylin-based obesity therapies.
AbbVie Inc. (ticker: ABBV) is developing ABBV-295. The company is running the clinical program for the drug in obesity and overweight with weight-related comorbidities, with two active trials currently recruiting participants in the United States and Puerto Rico.
ABBV-295 is in Phase 2 clinical development. It is investigational and has not received FDA approval. The Phase 2 trial is recruiting adults with obesity or overweight with weight-related comorbidities, and a separate Phase 1 study is also ongoing.
ABBV-295 is being studied in two active trials. NCT07752979 is a Phase 2 trial evaluating safety and efficacy in adults with obesity or overweight with weight-related comorbidities, enrolling 360 participants. NCT07291232 is a Phase 1 study assessing adverse events and pharmacokinetics in 80 adults with obesity.
ABBV-295 is a small molecule, but the Phase 1 trial NCT07291232 describes administration as subcutaneous injections. The Phase 2 trial NCT07752979 evaluates safety and efficacy in adults with obesity or overweight with weight-related comorbidities. Both studies are currently recruiting and are randomized, double-blind, and controlled.