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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02235961

Enrollment

163

Registered

2014-09-10

Start date

2014-09-04

Completion date

2016-07-06

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolism and Nutrition Disorder, Obesity

Brief summary

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.

Interventions

DRUGNNC9204-0530

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

DRUGliraglutide

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

DRUGplacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026