A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
Completed · Phase 1 · Has a placebo group
Conditions studied: Metabolism and Nutrition Disorder, Obesity
In brief
This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects being overweight or with obesity
Key facts
- Study ID
- NCT02835235
- Run by
- Novo Nordisk A/S
- People needed
- 48
- Starts
- 2016-07-26
- Expected to finish
- 2017-07-07
- Last updated by the study team
- 2018-01-08
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
- Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.
You may not qualify if…
- Haemoglobin A1c (HbA1c) equal or above 6.5%
- Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening
- Any prior obesity surgery or currently present gastrointestinal implant.
- Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
- A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
- History of pancreatitis (acute or chronic)
Where it is running
- Novo Nordisk Investigational Site — Tempe, Arizona, United States
- Novo Nordisk Investigational Site — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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