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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1289-3282 | Other Identifier | World Health Organization (WHO) |
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The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as injections under the skin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0487-0111 | Experimental | Participants will be randomized to receive NNC0487-0111. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD) |
|
| Placebo | Placebo Comparator | Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B,C,D and E: Multiple ascending dose (MAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0487-0111 | Drug | NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PART A: Number of treatment emergent adverse events (TEAE) | Number of events | From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 |
| PARTS B to E: Number of treatment emergent adverse events (TEAE) | Number of events | From pre-dose on Day 1 until completion of the end of study visit (V37) up to Day 270 |
| Measure | Description | Time Frame |
|---|---|---|
| PART A: AUC0-∞,SD; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose | h*nmol/L | From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 |
| PART A: Cmax,SD; the maximum plasma concentration of NNC0487-0111 after a single dose and the corresponding time tmax |
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Inclusion Criteria:
Exclusion Criteria:
Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening
Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services, LLC | San Antonio | Texas | 78209 | United States | ||
| Novo Nordisk INvestigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40550231 | Derived | Dahl K, Toubro S, Dey S, Duque do Vale R, Flint A, Gasiorek A, Heydorn A, Jastreboff AM, Key C, Petersen SB, Vegge A, Adelborg K. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study. Lancet. 2025 Jul 12;406(10499):149-162. doi: 10.1016/S0140-6736(25)01185-7. Epub 2025 Jun 20. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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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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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
| Placebo (NNC0487-0111) | Drug | Placebo matching NNC0487-0111 will be administered as a subcutaneous (s.c. under the skin) injection. |
|
nmol/L |
| From pre-dose on Day 1 until completion of the end of study visit, up to Day 25 |
| PARTS B to E: AUC0-168h,SS; the area under the NNC0487-0111 plasma concentration-time curve from time 0 to 168 hours after last multiple dose | h*nmol/L | From pre-dose on V33D1 until end of treatment (V34) up to 9 days |
| PARTS B to E: Cmax,SS; the maximum plasma concentration of NNC0487-0111 after last multiple dose and the corresponding time tmax | nmol/L | From pre-dose on V33D1 until end of study visit (V37) up to 24 days |
| PART B to E: Relative change in body weight | Percentage (%) | From pre-dose on Day 1 until end of treatment (V34) up to Day 255 |
| San Antonio |
| Texas |
| 78209 |
| United States |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |