Obesity, Overweight
Conditions
Brief summary
This study is testing a new medicine, NNC6989-0001, to test it is safe and tolerable for healthy people living with overweight or obesity. NNC6989-0001 is still being tested in studies and is not yet available for prescription by doctors. In this study, participants will receive either NNC6989-0001 or a placebo; which treatment each participant receives will be decided by chance.
Interventions
DRUGNNC6989-0001
Participants assigned to the active intervention receive NNC6989-0001
DRUGPlacebo (NNC6989-0001)
Participants assigned to the placebo, receive placebo matched in appearance to the active drug.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female of non-childbearing potential. * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) (at screening) ≥ 25.0 and ≤ 34.9 kg/m\^2 for Part A (SAD part) and BMI (at screening) ≥ 25.0 and ≤ 39.9 kg/m\^2 for Part B (MAD part) and Part C (meal timing and potentially meal composition). * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Any clinically significant body weight change (≥5 % self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening. * Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening * Use of prescription or non-prescription medicinal products within 14 days before screening. This includes over the counter medicines such as laxatives, mineral oil, and fat-blocking supplements. Routine multivitamin/mineral supplements at labelled daily doses are permitted; other non-prescription supplements (e.g., high-dose vitamins, weight-loss supplements) are not permitted. Occasional use of over-the-counter acetaminophen or NSAIDs at their labelled doses for mild pain is permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) - Part A | From time of dosing on Day1 until completion of the end of study visit (Day 7) | Measure in number of events. |
| Number of treatment emergent adverse events (TEAE) - Part B | From time of dosing on Day 1 until completion of the end of study visit (Day 14) | Measured in number of events |
| iAUCTG; The incremental area under the blood triglycerides concentration-time curve following meal test - Part C | Following meal test at Day -1, Day 1, Day 7 and Day 13 | Measured in ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part A | From pre-dose on Day 1 until completion of the end of study visit (Day 7) | Measured in hours times nanograms per millilitre(h\*ng/ml). |
| Cmax; the maximum plasma concentration of NNC6989-0001 - Part A | From pre-dose on Day 1 until completion of the end of study visit (Day 7) | Measured in nanograms per millilitre(ng/ml). |
| AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part B | From pre-dose on Day 1 until completion of the end of study visit (Day 14) | Measured in h\*ng/ml. |
| Cmax; the maximum plasma concentration of NNC6989-0001 - Part B | From pre-dose on Day 1 until completion of the end of study visit (Day 14) | Measured in ng/ml. |
| AUC; the area under the NNC6989-0001 plasma concentration-time curve - Part C | From pre-dose on Day 1 until completion of the end of study visit (Day 20) | Measured in h\*ng/ml. |
| Cmax; the maximum plasma concentration of NNC6989-0001 - Part C | From pre-dose on Day 1 until completion of the end of study visit (Day 20) | Measured in ng/ml. |
Countries
United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed