Research Study of a New Medicine (NNC9204-1706) in People With Overweight or Obesity
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|ClinicalTrials.gov Identifier: NCT03661879|
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolism and Nutrition Disorder Obesity||Drug: NNC9204-1706 Drug: Placebo (NNC9204-1706)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Five (5) cohorts are planned. In each cohort, subjects will be randomised in a 3:1 manner to receive either: 1) NNC9204-1706: 9 subjects or 2) Placebo (NNC9204-1706): 3 subjects|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Sponsor staff involved in the clinical trial is masked according to company standard procedures.|
|Official Title:||A Randomised, Double-blinded, Multiple-dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC9204-1706 in Subjects Being Overweight or With Obesity|
|Actual Study Start Date :||September 12, 2018|
|Actual Primary Completion Date :||September 5, 2019|
|Actual Study Completion Date :||October 9, 2019|
Participants will receive NNC9204-1706 for 10 weeks. There will be a 2-week follow-up period after the treatment period.
Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
Placebo Comparator: Placebo (NNC9204-1706)
Participants will receive placebo (NNC9204-1706) for 10 weeks. There will be a 2-week follow-up period after the treatment period.
Drug: Placebo (NNC9204-1706)
Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
- Number of treatment emergent adverse events (TEAEs) [ Time Frame: Days 1-84 ]Count of adverse events.
- Change in time-profile (msec) in individual corrected QT interval (ΔQTcI) [ Time Frame: Day 1, Day 84 ]Measured in msec.
- AUC0-24h,SS (h*nmol/L); the area under the NNC9204-1706 plasma concentration-time curve from time 0 to 24 hours at steady state [ Time Frame: Days 1-84 ]Measured in h*nmol/L.
- Cmax,SS (nmol/L); the maximum plasma concentration of NNC9204-1706 at steady state [ Time Frame: Days 1-84 ]Measured in nmol/L.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03661879
|United States, Kansas|
|Novo Nordisk Investigational Site|
|Overland Park, Kansas, United States, 66212|
|Study Director:||Clinical Reporting Anchor and Disclosure (1452)||Novo Nordisk A/S|