Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1333-6460 | Other Identifier | World Health Organization (WHO) | |
| 2026-525179-26 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.
The study consists of 5 Parts (Parts A to E and the participants will be assessed based on the study intervention received (NNC6022-0004 or Placebo).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC6022-0004 | Experimental | Participants will receive NNC6022-0004 administered orally as a single ascending dose (SAD), multiple ascending dose (MAD), or under fed/fasted conditions. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to NNC6022-0004 administered orally as a SAD, MAD, or under fed/fasted conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC6022-0004 | Drug | Participants will receive single dose of NNC6022-0004 administered orally in capsule form. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | Measured as micromolar per hour (µM*h). | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | Measured as micromolar (µM). | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part B: Number of treatment emergent adverse events (TEAE) | Measured as number of events. | From time of dosing (Day 1) to end of study visit (Day 14) |
| Part C: Number of treatment emergent adverse events | Measured as number of events. | From time of dosing (Day 1) to end of study visit (Day 41) |
| Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | Measured as µM*h. | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) |
| Part E: Number of treatment emergent adverse events | Measured as number of events. | From time of dosing (Day 1) to end of study visit (Day 13) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | Measured as µM*h. | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part A: Number of treatment emergent adverse events |
Not provided
Inclusion Criteria:
For optional Part E only: Age 18-65 years (both inclusive) at the time of signing the informed consent.
-For Parts A, B, C and D: Body mass index (BMI) between 18.5 to 29.9 kilogram per meter square (kg/m^2) (both inclusive) at screening.
For optional Part E only: BMI between greater than or equal to (≥) 30.0 to less than or equal to (≤) 45.0 kg/m^2 at screening, or if BMI is between 27.0 and <30.0 kg/m^2, waist to height ratio should be greater than (>)0.5.
Exclusion Criteria:
Known or suspected hypersensitivity to study intervention(s) or similar products.
Any disorder, unwillingness or inability which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Any of the below laboratory safety parameters at screening outside normal range, see designated reference range documents for specific values.
Alanine Aminotransferase (ALT) > Upper limit of normal (ULN).
Alkaline Phosphatase (ALP) > ULN.
Aspartate aminotransferase (AST) > ULN.
Total Bilirubin (TBL) > ULN.
Creatinine > ULN.
International normalized ratio (INR) > ULN.
Fibrinogen outside normal range of 1.6 - 4.2 grams per liter (g/L).
hsCRP > 5.00 mg/L (males) and > 8.00 mg/L (females)*.
Use of prescription medicinal products or vaccines within 14 days before screening and/or non prescription medicinal products within 7 days before dosing. Exceptions are: Topical medications not reaching systemic circulation; less than once per week of over-the-counter paracetamol, ibuprofen and/or acetylsalicylic acid at their labelled doses for mild pain; vitamins at their labelled doses.
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|---|---|---|
| ICON - location Groningen | Groningen | 9728 NZ | Netherlands |
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive placebo matched to NNC6022-0004 administered orally in capsule form. |
|
Measured as number of events.
| From time of dosing (Day 1) to end of study visit (Day 9) |
| Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose | Measured as µM*h. | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part B: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | Measured as µM*h. | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part B: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | Measured as µM. | From pre-dose (Day 1) until visit 3 (Day 9) |
| Part B: Proportion of administered dose recovered as unchanged drug in urine (Fe0-72h), calculated as Ae0-72hour/ dose | Measured as proportion of dose. | From dose (Day 1) until 72h post-dose |
| Part C: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after the last dose | Measured as µM*h. | From pre-dose (Day 28) to tau after last dose (Day 29) |
| Part C: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after last dose | Measured as µM. | From pre-dose (Day 28) until visit 3 (Day 35) |
| Part C: interleukin β (IL-1β) (ex vivo): ratio of plasma level at time tau after last dose to baseline | Measured as ratio | From pre-dose (Day 1) to tau after last dose (Day 29) |
| Part D: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to infinity (AUC0-∞) after a single dose | Measured as µM*h. | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) |
| Part D: The maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose | Measured as µM. | From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12) |
| Part D: Number of treatment emergent adverse events | Measured as number of events. | From time of dosing (Day 1) to end of visit (Day 16) |
| Part E: Ratio of plasma level at time tau after last dose to baseline (hsCRP) | Measured as ratio. | From pre-dose (Day 1) to tau after last dose (Day 8) |
| Part E: The area under the NNC6022-0001 plasma concentration-time curve from time 0 to tau (AUCtau) after last dose | Measured as µM*h . | From pre-dose (Day 7) to tau after last dose (Day 8) |
| Part E: The maximum observed plasma concentration (Cmax) of NNC6022 0001 after last dose | Measured as µM. | From pre-dose (Day 7) until visit 3 (Day 13) |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |