A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
2 other identifiers
interventional
48
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedStudy Start
First participant enrolled
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2017
CompletedJanuary 8, 2018
January 1, 2018
12 months
July 13, 2016
January 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of treatment emergent adverse events
Day 1-112
Secondary Outcomes (3)
Area under the NNC9204-0530 serum concentration-time curve
Day 84-112
Time to maximum serum concentration of NNC9204-0530
Day 84-112
Change in HbA1c
Day -1, Day 85
Study Arms (2)
NNC9204-0530
EXPERIMENTALDose-escalation within the cohort before reaching final dose
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (2)
Novo Nordisk Investigational Site
Tempe, Arizona, 85283, United States
Novo Nordisk Investigational Site
Lincoln, Nebraska, 68502, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2016
First Posted
July 18, 2016
Study Start
July 26, 2016
Primary Completion
July 7, 2017
Study Completion
July 7, 2017
Last Updated
January 8, 2018
Record last verified: 2018-01