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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 | Clinical Trials | Clareo Health

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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

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

NCT02870231•Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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)

Locations (2)

Novo Nordisk Investigational Site

Tempe, Arizona, United States

Novo Nordisk Investigational Site

Lincoln, Nebraska, United States

Key Dates

Start Date

August 18, 2016

Primary Completion Date

September 3, 2017

Completion Date

September 3, 2017

Last Updated

September 5, 2018

Enrollment

187

ACTUAL participants

Conditions

Metabolism and Nutrition DisorderObesity

Interventions

NNC9204-0530

DRUG

liraglutide

DRUG

placebo

DRUG

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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