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Completed

NCT Number: NCT02835235

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

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Tempe, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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)

Treatment and study plan

NNC9204-0530

Drug

Administered daily subcutaneously (s.c., under the skin)

Placebo

Drug

Administered daily subcutaneously (s.c., under the skin)

Primary outcomes

  1. Number of treatment emergent adverse events

    Time frame: Day 1-112

Secondary outcomes

  1. Area under the NNC9204-0530 serum concentration-time curve

    Time frame: Day 84-112

  2. Time to maximum serum concentration of NNC9204-0530

    Time frame: Day 84-112

  3. Change in HbA1c

    Time frame: Day -1, Day 85

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2016
Registry last updated
Jan 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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