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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: placebo

Drug: NNC9204-0530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02835235

NN9030-4295

U1111-1180-3542 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)