Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

Phase 1

Completed

• Conditions: Obesity; Metabolism and Nutrition Disorder
• Interventions: Drug: NNC0174-0833; Drug: Placebo

• Registration Number: NCT02958085
• 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, Pharmacokinetics (the exposure of the trial drug in the body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.

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: 2016-11-02
• Study Start: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-08
• Status Verified: 2018-01
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Male or female of non-childbearing potential (NCBP), aged 22-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 25.0 and 39.9 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

• History or presence of any clinically relevant respiratory, metabolic, renal, hepatic,gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or other major disorders including sleep apnoea or excessive sleepiness that might require medical attention
• History or presence of cardiovascular disease including stable and unstable angina, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, and heart failure
• History or presence of a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
• Male subject who is not surgically sterilised (vasectomy) and is sexually active with female partner(s) and 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) of childbearing potential (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 last dose of investigational medical product

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NNC0174-0833	NNC0174-0833	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From time of first dosing (Day 1) to the post-treatment follow-up visit (Day 99)

Secondary Outcome Measures

Name	Time	Method
The area under the NNC0174-0833 plasma concentration-time curve	From time 0 to 168 hours at steady state	\[only applicable for once weekly dosing\]
The maximum concentration of NNC0174-0833 in plasma at steady state	Day 1; Day 57

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Overland Park, Kansas, United States