NCT02235961

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

September 4, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2016

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

September 2, 2014

Last Update Submit

July 25, 2017

Conditions

Metabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Part 1

EXPERIMENTAL
Drug: NNC9204-0530Drug: placebo

Part 2

EXPERIMENTAL
Drug: NNC9204-0530Drug: liraglutideDrug: placebo

Interventions

NNC9204-0530DRUG

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

Part 1Part 2
liraglutideDRUG

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

Part 2
placeboDRUG

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

Part 1Part 2

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Links

MeSH Terms

Conditions

Nutrition DisordersObesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 10, 2014

Study Start

September 4, 2014

Primary Completion

July 6, 2016

Study Completion

July 6, 2016

Last Updated

July 27, 2017

Record last verified: 2017-07

Locations

US(1)