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Business objectives have changed
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The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Dose 1 or placebo | Experimental | Chinese participants |
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| Cohort 2: Dose 2 or placebo | Experimental | Chinese participants |
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| Cohort 3: Dose 1 or placebo | Experimental | Korean participants |
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| Cohort 4: Dose 2 or placebo | Experimental | Korean participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986036 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants | Up to 7 days after first dose and up to 7 days after last dose | |
| Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants | Up to 7 days after first dose and up to 7 days after last dose | |
| Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants | Up to 7 days after first dose and up to 7 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Up to 45 days | |
| Incidence of serious adverse events (SAEs) | Up to 70 days | |
| Incidence of clinically significant changes in vital signs: Body temperature |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Changchun | Jilin | 130021 | China | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C000630067 | Pegbelfermin |
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|
| Placebo | Other | Specified dose on specified days |
|
| Up to 64 days |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 64 days |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 64 days |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 64 days |
| Incidence of clinically significant changes in physical examination findings | Up to 64 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval is the time from the onset of the P wave to the start of the QRS complex | Up to 64 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization | Up to 64 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | The QT interval is the time from the start of the Q wave to the end of the T wave | Up to 64 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 64 days |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 64 days |
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 64 days |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 64 days |
| Busan |
| 614-735 |
| South Korea |
| FDA Safety Alerts and Recalls | View source |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |