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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02870231
• Other study ID #: NN9030-4130
• Secondary ID: U1111-1175-7040
• Status: Completed
• Phase: Phase 1
• Start date: August 18, 2016
• Est. completion date: September 3, 2017

Study information

• Verified date: September 2018
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: September 3, 2017
• Est. primary completion date: September 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity
• Overweight

Intervention

Drug:
• NNC9204-0530
Once-daily subcutaneous (s.c., under the skin) administration.
• liraglutide
Once-daily subcutaneous (s.c., under the skin) administration.
• placebo
Once-daily subcutaneous (s.c., under the skin) administration

Locations

Country	Name	City	State
United States	Novo Nordisk Investigational Site	Lincoln	Nebraska
United States	Novo Nordisk Investigational Site	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment emergent adverse events		Day 1-112
Secondary	Area under the NNC9204-0530 serum concentration-time curve		Day 84-112
Secondary	Time to maximum serum concentration of NNC9204-0530		Day 84-112
Secondary	Change in HbA1C		Day -1, Day 85

External Links

•   Clinical Trials at Novo Nordisk