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

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.

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.

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

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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