Skip to main content
OpenTrials
Completed

NCT Number: NCT02235961

Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of NNC9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolism and Nutrition Disorder Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male, age between (both inclusive) 18 and 55 years at the time of signing inform consent
  • Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m^2

Exclusion criteria

  • Thyroid stimulating hormone values outside 0.4-6.0 mIU/l
  • HbA1c (glycated hemoglobin) above or equal to 6.5%
  • Any clinically relevant ECG (electrocardiogram) findings (e.g. 2nd or 3rd degree AV-block), in particular subjects with repeated demonstration of a QTcF (QT interval corrected by Fridericia formula) interval above 430 ms
  • A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  • The use of concomitant medications that prolong the QT/QTc interval
  • Obesity caused by endocrinology disorders (e.g. Cushing's Syndrome)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Calcitonin above 50 ng/L
  • History of pancreatitis (acute or chronic)

Treatment and study plan

NNC9204-0530

Drug

Administered as single subcutaneous (s.c., under the skin) injections.

liraglutide

Drug

Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.

Placebo

Drug

Administered as single subcutaneous (s.c., under the skin) injections.

Primary outcomes

  1. Number of treatment emergent adverse events recorded

    Time frame: From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)

Secondary outcomes

  1. Area under the NNC9204-0530 serum concentration-time curve

    Time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

  2. Maximum concentration of NNC9204-0530 in serum

    Time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

  3. The time to maximum concentration of NNC9204-0530 in serum

    Time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

  4. The terminal half-life of NNC9204-0530

    Time frame: From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2014
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.