Investigation of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of NNC0480-0389 in combination with semaglutide s.c.
- Conditions
- diabetes10018424
- Registration Number
- NL-OMON55332
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 156
SAD part
- Male aged 18-45 years (both inclusive) at the time of signing informed
consent.
- BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive).
MAD part (not applicable for PoC cohort)
- BMI between 20.0 kg/m2 and 29.9 kg/m2 (both inclusive).
- Female of non-childbearing potential or male aged 18-55 years (both
inclusive) at the time of signing informed consent.
MAD part (only applicable for PoC cohort)
- BMI between 25.0 kg/m2 and 39.9 kg/m2 (both inclusive). Overweight or obesity
should be due to excess adipose tissue, as judged by the investigator.
-Female of non-childbearing potential or male aged 18-64 years (both inclusive)
at the time of signing informed consent.
-Subjects treated with diet and exercise as monotherapy or in combination with
1-2 of the following anti-diabetic drug(s) at a stable dose for at least 30
days prior to screening: metformin, sulfonylureas, meglitinides, DPP-4
inhibitors, alpha-glucosidase inhibitors,
thiazolidinediones, GLP-1 receptor agonists or SLGT-2 inhibitors. The metformin
dose should be >= 1500 mg to <= 3000 mg or maximum tolerated or effective dose
documented in subject's medical record.
- Any disorder (except for conditions associated with T2D for the PoC cohort
included in the MAD part) which in the investigator*s opinion might jeopardise
subject*s safety or compliance with the protocol.
- HbA1c >= 6.5 % (48 mmol/mol) at screening (except for MAD part only applicable
for PoC cohort).
- Use of prescription medicinal products or non-prescription drugs, except
routine vitamins,
occasional use of acetaminophen, ibuprofen and acetylsalicylic acid, or topical
medication not
reaching systemic circulation within 14 days prior to the day of screening
(except for the MAD part only applicable for PoC cohort).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>SAD part<br /><br>To investigate the safety and tolerability of single doses of NNC0480-0389<br /><br>subcutaneously coadministered<br /><br>with semaglutide in healthy male subjects.<br /><br><br /><br>MAD part<br /><br>To investigate the safety and tolerability of multiple doses of NNC0480-0389<br /><br>subcutaneously<br /><br>co-administered with semaglutide in healthy subjects</p><br>
- Secondary Outcome Measures
Name Time Method <p>SAD part<br /><br>To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous<br /><br>co-administration of single doses of NNC0480-0389 and semaglutide in healthy<br /><br>male subjects<br /><br><br /><br>MAD part:<br /><br>To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous<br /><br>co-administration of multiple doses of NNC0480-0389 and semaglutide in healthy<br /><br>subjects<br /><br><br /><br>MAD/POC part<br /><br>To investigate the safety and tolerability of multiple doses of NNC0480-0389<br /><br>subcutaneously co-administered with semaglutide in subjects with type 2<br /><br>diabetes<br /><br><br /><br>To investigate the pharmacokinetics of NNC0480-0389 upon subcutaneous<br /><br>co-administration of multiple doses of NNC0480-0389 and semaglutide in subjects<br /><br>with type 2 diabetes</p><br>