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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1335-9475 | Other Identifier | World Health Organization |
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The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get zenagamtide (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 |
|---|---|---|---|
| Zenagamtide | Experimental | Participants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly. |
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| Placebo | Placebo Comparator | Participants will receive placebo matched to Zenagamtide subcutaneously once weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zenagamtide | Drug | Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative change in body weight | Measured as percentage of body weight. | From baseline (week 0) to week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | Measured as centimetre (cm). | From baseline (week 0) to week 80 |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Nirmal Hospital Pvt. Ltd. | Surat | Gujarat | 395002 | India | ||
| SSG Hospital, Baroda |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo ( matched to Zenagamtide) | Drug | Placebo matched to Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. |
|
| Vadodara |
| Gujarat |
| 390001 |
| India |
| Shree Mahalaxmi DIATONE Institute | Kohlapur | Maharashtra | 416001 | India |
| Excel Endocrine Centre | Kolhāpur | Maharashtra | 416008 | India |
| Maulana Azad Medical College | Delhi | New Delhi | 110002 | India |
| Diabetes Research Center, Hyderabad | Hyderabad | Telangana | 500 082 | India |
| SMS Hospital | Jaipur | 302004 | India |
| OCROM Clinic_Internal medicine | Suita-shi | Osaka | 565-0853 | Japan |
| Tokyo-Eki Center-building Clinic_Internal Medicine | Tokyo | 103-0027 | Japan |
| Fukuwa Clinic_Internal Medicine | Tokyo | 104-0031 | Japan |
| ToCROM Clinic_Internal Medicine | Tokyo | 160-0008 | Japan |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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