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

• ClinicalTrials.gov Identifier: NCT02235961
• Recruitment Status: Completed
• First Posted: September 10, 2014
• Last Update Posted: July 27, 2017
• Sponsor: Novo Nordisk A/S
• Information provided by (Responsible Party): Novo Nordisk A/S

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolism and Nutrition Disorder; Obesity	Drug: NNC9204-0530; Drug: liraglutide; Drug: placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 163 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official 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.
• Actual Study Start Date: September 4, 2014
• Actual Primary Completion Date: July 6, 2016
• Actual Study Completion Date: July 6, 2016

Arms and Interventions

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: liraglutide; Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.; Drug: placebo; Administered as single subcutaneous (s.c., under the skin) injections.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

United States, Kansas

Novo Nordisk Investigational Site

Overland Park, Kansas, United States, 66212

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452); Novo Nordisk A/S

More Information

Additional Information:

Clinical Trials at Novo Nordisk 

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT02235961
• Other Study ID Numbers: NN9030-4111; U1111-1151-0761 ( Registry Identifier: WHO )
• First Posted: September 10, 2014
• Last Update Posted: July 27, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Nutrition Disorders; Overweight; Body Weight; Liraglutide; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists