First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Phase 1

Completed

• Conditions: Obesity; Metabolism and Nutrition Disorder
• Interventions: Drug: NNC0194-0499; Drug: Placebo

• Registration Number: NCT03015207
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or 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: 2017-01-06
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-03
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

• Male, aged 22-55 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). Overweight should be due to excess adipose tissue, as judged by the investigator

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Exclusion Criteria

• Any concomitant illness or disorder, which in the investigator's opinion might jeopardise the subject's safety or compliance with the protocol
• Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD according to ACC/AHA (American College of Cardiology /American Heart Association) 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) 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 (visit 1) until 3 months following administration of the investigational medical product
• Use of prescription or non-prescription medicinal products including herbal products and non-routine vitamins, within 2 weeks prior to screening, with the exception of occasional use of acetaminophen, ibuprofen or acetylsalicylic acid

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC0194-0499	NNC0194-0499	Injected s.c. /subcutaneously (under the skin)
Placebo	Placebo	Injected s.c. /subcutaneously (under the skin)

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events (TEAEs)	From time of administration of NNC0194-0499 (day 1) to completion of the post-treatment period at follow-up (day 36)

Secondary Outcome Measures

Name	Time	Method
The area under the NNC0194-0499 serum concentration-time curve after a single subcutaneous administration	From pre-dose (day 1) until the followup (day 36)
The time to maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration	From pre-dose (day 1) until the followup (day 36)
The maximum concentration of NNC0194-0499 in serum after a single subcutaneous administration	From pre-dose (day 1) until the followup (day 36)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 San Antonio, Texas, United States