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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1324-3831 | Other Identifier | World Health Organization (WHO) |
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The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - UBT251 | Experimental | Participants will be randomized to receive multiple dose levels subcutaneously. |
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| Part A - placebo | Placebo Comparator | Participants will receive placebo matched to UBT251 subcutaneously. |
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| Part B - Arm A (UBT251) | Experimental | Participants will be randomized to receive multiple dose levels subcutaneously. |
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| Part B - Arm B (UBT251) | Experimental | Participants will be randomized to receive multiple dose levels subcutaneously. |
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| Part B - Arm C (UBT251) | Experimental | Participants will be randomized to receive multiple dose levels subcutaneously. |
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| Part B - Arm D (UBT251) | Experimental | Participants will be randomized to receive 2 dose levels subcutaneously. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UBT251 | Drug | UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A - Number of treatment emergent adverse events (TEAEs) | Measured as Number of events. | From baseline (week 0) to end of study (week 33) |
| Part B - Relative change in body weight | Measured as percentage of body weight. | From baseline (week 0) to end of treatment (week 28) |
| Part C- AUC; the area under the UBT251 plasma concentration time curve | Measured as hour*nanomoles per liter (h*nmol/L) | From pre-dose on Day 1 until completion of the end of study visit (Day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A - Relative change in body weight | Measured as percentage of body weight. | From baseline (week 0) to end of treatment (week 28) |
| Part A - Change in body weight | Measured as kilogram (kg). |
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Inclusion Criteria:
Male or female (sex at birth).
For Part C: Japanese, Chinese or non-Asian participants (all self-reported):
Age at the time of signing the informed consent:
BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):
Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical LA, Inc. | Recruiting | Cypress | California | 90630 | United States | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Part B - Arm E (UBT251) | Experimental | Participants will be randomized to receive a single dose level subcutaneously. |
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| Part B - placebo | Placebo Comparator | Participants will receive placebo matching one of the UBT251 arms subcutaneously. |
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| Part C - UBT251 dose 1 | Experimental | Participants will be randomized to receive dose level 1 subcutaneously. |
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| Part C - UBT251 dose 2 | Experimental | Participants will be randomized to receive dose level 2 subcutaneously. |
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| Part C - UBT251 dose 3 | Experimental | Participants will be randomized to receive dose level 3 subcutaneously. |
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| Placebo | Drug | Placebo matched to UBT251 injection will be administered subcutaneously in a lifted fold of the abdominal skin. |
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| From baseline (week 0) to end of treatment (week 28) |
| Part A - AUC; the area under the UBT251 plasma concentration-time curve | Measured as h*nmol/L | From pre-dose on day 1 to end of study (week 33) |
| Part A - Cmax; the maximum plasma concentration of UBT251 | Measured as nanomole per liter (nmol/L) | From pre-dose on day 1 to end of study (week 33) |
| Part B - Change in body weight | Measured as kg. | From baseline (week 0) to end of treatment (week 28) |
| Part B - Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to end of treatment (week 28) |
| Part B - Number of TEAEs | Measured as number of events | From baseline (week 0) to end of study (week 33) |
| Part C - Cmax; the maximum plasma concentration of UBT251 | Measured as nmol/L | From pre-dose on Day 1 until completion of the end of study visit (Day 43) |
| Part C - Number of treatment-emergent adverse events (TEAEs) | Measured as number of events. | From pre-dose on Day 1 until completion of the end of study visit (Day 43) |
| Altasciences Clinical Kansas, Inc. |
| Recruiting |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| Altasciences Clinical Company, Inc | Recruiting | Montreal | Quebec | H3P 3P1 | Canada |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |