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

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.

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolism and Nutrition Disorder
• Intervention / Treatment: Drug: NNC9204-0530; Drug: placebo; Drug: liraglutide

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1	Drug: NNC9204-0530; Administered as single subcutaneous (s.c., under the skin) injections.; Drug: placebo; Administered as single subcutaneous (s.c., under the skin) injections.
Experimental: Part 2	Drug: NNC9204-0530; Administered as single subcutaneous (s.c., under the skin) injections.; Drug: placebo; Administered as single subcutaneous (s.c., under the skin) injections.; Drug: liraglutide; Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment emergent adverse events recorded	From time of dosing of NNC9204-0530 (Day 1) until completion of the follow-up visit (Day 21-27)

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the NNC9204-0530 serum concentration-time curve	From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
Maximum concentration of NNC9204-0530 in serum	From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
The time to maximum concentration of NNC9204-0530 in serum	From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points
The terminal half-life of NNC9204-0530	From dosing visit to infinity calculated on 0-24 days NNC9204-0530 serum concentration-curve based on 21 sampling points

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2014
• Primary Completion (Actual): July 6, 2016
• Study Completion (Actual): July 6, 2016

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 5, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Overweight; Nutrition Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN9030-4111; U1111-1151-0761 (Registry Identifier: WHO)