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

Obesity Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835235
• Other study ID #: NN9030-4295
• Secondary ID: U1111-1180-3542
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2016
• Last updated: January 5, 2018
• Start date: July 26, 2016
• Est. completion date: July 7, 2017

Study information

• Verified date: January 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 7, 2017
• Est. primary completion date: July 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• NNC9204-0530
Administered daily subcutaneously (s.c., under the skin)
• placebo
Administered daily subcutaneously (s.c., under the skin)

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