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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-295 or Placebo-Group 1 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
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| ABBV-295 or Placebo-Group 2 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
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| ABBV-295 or Placebo-Group 3 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
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| ABBV-295 or Placebo-Group 4 | Experimental | Participants will receive subcutaneous doses of ABBV-295 or Placebo for 13 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-295 | Drug | Subcutaneous Injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | 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. | Up to approximately 145 days |
| Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements | Number of participants with abnormal change from baseline in vital sign measurements like heart rate, systolic and diastolic blood pressure will be assessed. | Up to approximately 145 days |
| Number of Participants with Change from Baseline in Electrocardiogram (ECG) | 12-lead resting ECG will be recorded. | Up to approximately 145 days |
| Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed | Number of participants with abnormal change in clinical laboratory test results like biochemistry, hematology will be assessed. | Up to approximately 145 days |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-295 | Cmax of ABBV-295 | Up to approximately 145 days |
| Time to Cmax (Tmax) of ABBV-295 | Tmax of ABBV-295 | Up to approximately 145 days |
| Trough plasma concentration (Ctrough) of ABBV-295 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 283200 | Recruiting | Anaheim | California | 92801 | United States | |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Subcutaneous Injections |
|
Ctrough of ABBV-295 |
| Up to approximately 145 days |
| Apparent terminal phase elimination rate constant (BETA) of ABBV-295 | BETA of ABBV-295 | Up to approximately 145 days |
| Terminal phase elimination half-life (t1/2) of ABBV-295 | t1/2 of ABBV-295 | Up to approximately 145 days |
| Area under the plasma concentration-time curve (AUC) of ABBV-295 | AUC of ABBV-295 | Up to approximately 145 days |
| Area under the plasma concentration-time curve over the dosing interval (AUCtau) of ABBV-295 | AUCtau of ABBV-295 | Up to approximately 145 days |
| Dose Normalized Cmax of ABBV-295 | Dose normalized Cmax of ABBV-295 will be assessed. | Up to approximately 145 days |
| Dose Normalized AUC of ABBV-295 | Dose normalized AUC of ABBV-295 will be assessed. | Up to approximately 145 days |
| Incidence of Anti-Drug Antibodies (ADAs) | Incidence of ADAs will be assessed. | Up to approximately 145 days |
| Percent Change in Body Weight From Baseline | Percent change in body weight (kg) will be assessed. | Up to approximately 145 days |
| Acpru /Id# 278624 |
| Recruiting |
| Grayslake |
| Illinois |
| 60030 |
| United States |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |