A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: placebo; Drug: NNC9204-0530

• Registration Number: NCT02835235
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female 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: 2016-07-13
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Study Start: 2016-07-26
• Primary Completion: 2017-07-07
• Study Completion: 2017-07-07
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
• Body mass index between 25.0 and 39.9 kg/m^2 (both inclusive) at screening.

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Exclusion Criteria

• Haemoglobin A1c (HbA1c) equal or above 6.5%
• Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening
• Any prior obesity surgery or currently present gastrointestinal implant.
• Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
• A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
• History of pancreatitis (acute or chronic)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC9204-0530	NNC9204-0530	Dose-escalation within the cohort before reaching final dose

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events	Day 1-112

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c	Day -1, Day 85
Time to maximum serum concentration of NNC9204-0530	Day 84-112
Area under the NNC9204-0530 serum concentration-time curve	Day 84-112

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Lincoln, Nebraska, United States