A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Phase 1

Completed

• Conditions: Obesity; Metabolism and Nutrition Disorder
• Interventions: Drug: NNC9204-1177; Drug: Placebo

• Registration Number: NCT02941042
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in 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 First Submitted: 2016-10-07
• Study Start: 2016-10-10
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

Inclusion Criteria

• Male, 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

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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 above or equal to 5%
• Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) 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
NNC9204-1177	NNC9204-1177	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From time of dosing (day 1) until completion of the follow-up visit (day 39)

Secondary Outcome Measures

Name	Time	Method
Change in body weight	Day 1, day 39
Area under the NNC9204-1177 serum concentration-time curve	From 0 to 168 hours after a single s.c. dose
Maximum serum concentration of NNC9204-1177	From time of dosing (day 1) until completion of the follow-up visit (day 39)	Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39
Time to maximum serum concentration of NNC9204-1177	From time of dosing (day 1) until completion of the follow-up visit (day 39)	Sampling was done day 1, 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 39
Change in QT interval corrected using the Fridericia formula (QTcF)	Day 1, day 39

Trial Locations

Locations (1)

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