Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460, Germany
Location status: Recruiting
NCT Number: NCT07578584
The purpose of this clinical study is to find out if NNC0497-0040 is safe, tolerable and effective for healthy people living with normal weight or overweight, people living with overweight or obesity and people who have type 1 diabetes and are living with overweight or obesity. There are 2 study treatments in this study, where participants will get either NNC0497-0040, the new treatment being tested or placebo, a treatment that has no active medicine in it. Participants will be in this clinical study for up to 29 weeks.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 1
Neuss, 41460, Germany
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For SAD cohorts
Inclusion criteria
Exclusion criteria
For MAD1-3 cohorts
Inclusion criteria
Exclusion criteria
For MAD4 cohorts
Inclusion criteria
Exclusion criteria
NNC0497-0040 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Time frame: Day 1 up to Week 6
Measured in events
Time frame: MAD1-2: Day 1 up to Week 17; MAD3: Day 1 up to Week 25
Measured in events
Time frame: Day 1 up to Week 25
Measured in events
Time frame: Day 1
Measured in hours * nanomoles per litre (h*nmol/L)
Time frame: Day 1
Measured in nanomoles per litre (nmol/L)
Time frame: MAD1-2: Week 12; MAD3: Week 20
Measured in hours * nanomoles per litre (h*nmol/L)
Time frame: MAD1-2: Week 12; MAD3: Week 20
Measured in nanomoles per litre (nmol/L)
Time frame: Day 1 up to Week 25
Measured in events
Time frame: MAD4: Week 20
Measured in hours * nanomoles per litre (h*nmol/L)
Time frame: MAD4: Week 20
Measured in nanomoles per litre (nmol/L)
Contact information is provided by the study sponsor or research team.
Novo Nordisk A/S
Industry
Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Weekly Doses of NNC0497-0040 in Healthy Participants, Participants With Overweight or Obesity, and in Participants With Type 1 Diabetes With Overweight or Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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