A Research Study of How NNC0174-0833 Behaves in Japanese and Caucasian Volunteers Who Are Normal Weight, Overweight or With Obesity

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT03787225

Collaborator

(none)

Enrollment

Location

Arms

4.9

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a "dummy" medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.

Condition or Disease	Intervention/Treatment	Phase
Obesity Overweight	Drug: NNC0174-0833 Drug: Placebo (NNC0174-0833)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Primary Purpose:

Treatment

Official Title:

Investigation of Pharmacokinetic Properties, Safety and Tolerability of Single Subcutaneous Doses of NNC0174-0833 in Male Japanese and Caucasian Subjects Being Normal Weight, Overweight or With Obesity

Actual Study Start Date :

Jan 7, 2019

Actual Primary Completion Date :

Jun 4, 2019

Actual Study Completion Date :

Jun 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NNC0174-0833 (0.3 mg) Participants will receive single dose of NNC0174-0833	Drug: NNC0174-0833 Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
Experimental: NNC0174-0833 (0.9 mg) Participants will receive single dose of NNC0174-0833	Drug: NNC0174-0833 Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
Experimental: NNC0174-0833 (1.8 mg) Participants will receive single dose of NNC0174-0833	Drug: NNC0174-0833 Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
Placebo Comparator: Placebo (NNC0174-0833) Participants will receive placebo (NNC0174-0833)	Drug: Placebo (NNC0174-0833) Participants will receive NNC0174-0833 matched placebo subcutaneously.

Outcome Measures

Primary Outcome Measures

AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose [From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)]
Measured in h*nmol/L

Secondary Outcome Measures

Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma [From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36)]
Measured in nmol/L
Number of treatment emergent adverse events (TEAEs) [From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36)]
Count of events

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Male, aged 18-55 years (both inclusive) at the time of signing informed consent.
For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
For Caucasian subjects, self-reported European descent or white Latin-American descent.
Body mass index (BMI) between 20.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
Body weight between 60 and 110 kg (both inclusive) at screening

Exclusion Criteria:

Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner[s] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product.
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Glendale	California	United States	91206

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Clinical Reporting Anchor and Disclosure 1452, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT03787225

Other Study ID Numbers:

NN9838-4483
U1111-1219-7303

First Posted:

Dec 26, 2018

Last Update Posted:

Jun 24, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity

Overweight

Study Results

No Results Posted as of Jun 24, 2019