Investigation of Single Ascending Doses of NNC9204-1706 in Male Subjects Being Overweight or With Obesity

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: NNC9204-1706 A; Drug: Placebo

• Registration Number: NCT03095807
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to assess the safety and tolerability of single doses of NNC9204-1706 administered subcutaneously in male subjects being overweight or with obesity.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-03-24
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-03-30
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

• Male subjects aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 25.0 and 34.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess of adipose tissue, as judged by the investigator

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Exclusion Criteria

• Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
• Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk equal to or above 5%
• Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) and who are 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 below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NNC9204-1706 A	NNC9204-1706 A	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events (TEAEs)	From the time of dosing (Day 1) and until completion of the post-treatment follow-up visit (Days 10-13)	Count and % of events

Secondary Outcome Measures

Name	Time	Method
Maximal observed concentration of the NNC9204-1706 plasma concentration curve	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
The apparent volume of distribution of NNC9204-1706	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Changes in Body weight	Day 1, Days 10-13	Measured in kg and/or %
Number of injection-site reactions	From the time of dosing (Day 1) to the follow-up visit (Days 10-13)	Count of reactions
Number of hypoglycaemic episodes	from time of dosing (Day 1) to the follow-up visit (Days 10-13)	Count of episodes
Area under the NNC9204-1706 plasma concentration-time curve	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Area under the NNC9204-1706 plasma concentration-time curve (0-24h)	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Area under the NNC9204-1706 plasma concentration-time curve (0- to last quantifiable sample)	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
The apparent total plasma clearance of NNC9204-1706	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Time to observed maximum concentration of NNC9204-1706 in plasma	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Mean residence time of NNC9204-1706	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.
Terminal half-life of NNC9204-1706	Day 1- Day 7	Calculated based on NNC9204-1706 measured in blood.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Baltimore, Maryland, United States