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OpenTrials
Completed

NCT Number: NCT02870231

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

This trial is conducted in the United States of America. The aim of this trial is to investigate Safety, Tolerability, PK (the exposure of the trial drug in the body) and PD (the effect of the investigated drug on the body) for Multiple Doses of NNC9204-0530 in Combination with Liraglutide 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

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

Exclusion criteria

  • Any clinically significant weight change (equal or above 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.
  • Thyroid-stimulating hormone (TSH) values outside 0.4-6.0 mIU/L
  • Glycosylated haemoglobin (HbA1c)above or equal to 6.5% or in Système International (SI) units 48 mmol/mol
  • 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)
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
  • Calcitonin above or equal to 50 ng/L
  • History of pancreatitis (acute or chronic)

Treatment and study plan

NNC9204-0530

Drug

Once-daily subcutaneous (s.c., under the skin) administration.

liraglutide

Drug

Once-daily subcutaneous (s.c., under the skin) administration.

Placebo

Drug

Once-daily subcutaneous (s.c., under the skin) administration

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 17, 2016
Registry last updated
Sep 5, 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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