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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Metabolism and Nutrition Disorder, Obesity

Intervention / Treatment
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* Drug: NNC9204-0530
* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC9204-0530 / Placebo and Liraglutide 1.8<br> | Drug: NNC9204-0530<br>* Once-daily subcutaneous (s.c., under the skin) administration.<br>Drug: liraglutide<br>* Once-daily subcutaneous (s.c., under the skin) administration.<br>Drug: placebo<br>* Once-daily subcutaneous (s.c., under the skin) administration<br>|
| Active Comparator: NNC9204-0530 /Placebo and Liraglutide 3.0<br> | Drug: NNC9204-0530<br>* Once-daily subcutaneous (s.c., under the skin) administration.<br>Drug: liraglutide<br>* Once-daily subcutaneous (s.c., under the skin) administration.<br>Drug: placebo<br>* Once-daily subcutaneous (s.c., under the skin) administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events |  | Day 1-112 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the NNC9204-0530 serum concentration-time curve |  | Day 84-112 | 
| Time to maximum serum concentration of NNC9204-0530 |  | Day 84-112 | 
| Change in HbA1C |  | Day -1, Day 85 |