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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
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• Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.

• Body mass index between 18.5 kilogram per m\^2 and 29.9 kilogram per m\^2 (both inclusive) at screening.

• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

• Female of non-childbearing potential or male aged 18-55 years (both inclusive) at screening.

• Body mass index between 27.0 kilogram per m\^2 and 39.9 kilogram per m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

• Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

• Male aged 18-55 years (both inclusive) at screening.

• Body mass index between 27.0 kilogram per m\^2 and 34.9 kilogram per m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

• Diagnosed with type 1 diabetes mellitus above or equal to 1 year before screening.

• Treated with multiple daily insulin injections (daily basal insulin analogue and bolus insulin analogue regimen) more than 90 days prior to the day of screening.

• Use of continuous glucose monitoring (CGM) device more than 90 consecutive days prior to the day of screening.

• HbA1c in the range of 7.2percentage - 9.5percentage (both inclusive).

Locations
Other Locations
Germany
Profil Institut für Stoffwechselforschung GmbH
RECRUITING
Neuss
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2026-05-07
Estimated Completion Date: 2028-02-18
Participants
Target number of participants: 146
Treatments
Experimental: SAD
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Experimental: MAD1
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Experimental: MAD2
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Experimental: MAD3
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Experimental: MAD4
Participants will receive NNC0497-0040 or placebo matched to NNC0497-0040 subcutaneously.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov