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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Metabolism and Nutrition Disorder

Obesity

Treatments

Drug: placebo

Drug: liraglutide

Drug: NNC9204-0530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02870231

U1111-1175-7040 (Other Identifier)

NN9030-4130

Details and patient eligibility

About

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

Enrollment

187 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No 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)