Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-295 · 4 trials · 3 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 Part 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 1 | EXPERIMENTAL | Participants will receive subcutaneous doses of placebo for 12 weeks. |
| ABBV-295 Part 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 for 12 weeks. |
| Placebo for ABBV-295 Part 2 | EXPERIMENTAL | Participants will receive subcutaneous doses of placebo for 12 weeks. |
| ABBV-295 with Levonorgestrel and Ethinyl Estradiol | EXPERIMENTAL | Participants will receive subcutaneous doses of ABBV-295 with levonorgestrel and ethinyl estradiol for 68 days. |
| 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 |
| Placebo for ABBV-295 | DRUG | Subcutaneous Injections |
| Levonorgestrel/Ethinyl Estradiol | DRUG | Oral Tablet |
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 developed for obesity and overweight with weight-related comorbidities. It is administered as a subcutaneous injection and is currently in Phase 1 and Phase 2 clinical trials. The drug targets the hormone amylin, which plays a role in regulating appetite and body weight.
ABBV-295 targets amylin, a hormone involved in regulating appetite and energy balance. By acting on this target, the drug is being studied for its potential to treat obesity and overweight. It is administered as a subcutaneous injection and is currently in clinical development for these conditions.
ABBV-295 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 and Phase 2 clinical trials for obesity and overweight, administered as a subcutaneous injection.
ABBV-295 is in Phase 1 and Phase 2 clinical development. It is not FDA approved and remains investigational. Phase 1 trials are assessing safety, tolerability, and pharmacokinetics in healthy volunteers and participants with obesity, while a Phase 2 trial is evaluating safety and efficacy in adults with obesity or overweight with weight-related comorbidities.
ABBV-295 is being studied in several clinical trials. NCT07291232 is a Phase 1 study in adults with obesity. NCT07414784 is a completed Phase 1 study in healthy adult women with overweight or obesity taking oral contraceptives. NCT07514260 is a Phase 1 study in healthy Japanese participants with overweight or obesity. NCT07752979 is a Phase 2 study in adults with obesity or overweight with weight-related comorbidities.
ABBV-295 is a distinct investigational small molecule that targets amylin, a hormone involved in appetite regulation. It is not the same as other marketed obesity drugs, which may target different pathways such as GLP-1. ABBV-295 is being developed by AbbVie and is currently in clinical trials for obesity and overweight.