- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02870231
Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
September 3, 2018 updated by: Novo Nordisk A/S
A Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Combination With Liraglutide in Male and Female Subjects Being Overweight or With Obesity
This trial is conducted in the United States of America.
The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide in Male and Female Subjects being Overweight or with Obesity
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
187
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Novo Nordisk Investigational Site
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.
- Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
Exclusion Criteria:
- Any clinically significant weight change (equal or above 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.
- Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
- Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
- 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)
- Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
- Calcitonin above or equal to 50 ng/L
- History of pancreatitis (acute or chronic)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NNC9204-0530 / Placebo and Liraglutide 1.8
|
Once-daily subcutaneous (s.c., under the skin) administration.
Once-daily subcutaneous (s.c., under the skin) administration.
Once-daily subcutaneous (s.c., under the skin) administration
|
Active Comparator: NNC9204-0530 /Placebo and Liraglutide 3.0
|
Once-daily subcutaneous (s.c., under the skin) administration.
Once-daily subcutaneous (s.c., under the skin) administration.
Once-daily subcutaneous (s.c., under the skin) administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of treatment emergent adverse events
Time Frame: Day 1-112
|
Day 1-112
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the NNC9204-0530 serum concentration-time curve
Time Frame: Day 84-112
|
Day 84-112
|
Time to maximum serum concentration of NNC9204-0530
Time Frame: Day 84-112
|
Day 84-112
|
Change in HbA1C
Time Frame: Day -1, Day 85
|
Day -1, Day 85
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2016
Primary Completion (Actual)
September 3, 2017
Study Completion (Actual)
September 3, 2017
Study Registration Dates
First Submitted
August 12, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (Estimate)
August 17, 2016
Study Record Updates
Last Update Posted (Actual)
September 5, 2018
Last Update Submitted That Met QC Criteria
September 3, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9030-4130
- U1111-1175-7040 (Other Identifier: WHO)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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