Metabolism and Nutrition Disorder, Obesity
Conditions
Brief 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
Interventions
DRUGliraglutide
Once-daily subcutaneous (s.c., under the skin) administration.
DRUGplacebo
Once-daily subcutaneous (s.c., under the skin) administration
DRUGNNC9204-0530
Once-daily subcutaneous (s.c., under the skin) administration.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of treatment emergent adverse events | Day 1-112 |
Secondary
| Measure | Time frame |
|---|---|
| Time to maximum serum concentration of NNC9204-0530 | Day 84-112 |
| Change in HbA1C | Day -1, Day 85 |
| Area under the NNC9204-0530 serum concentration-time curve | Day 84-112 |
Countries
United States
Outcome results
None listed