A Randomized, Placebo Controlled and Double-blinded Study Assessing the Safety, Tolerability, Pharmacokinetics, and Efficacy of Subcutaneous Administrations of NNC0174 1213 in Male Participants With Overweight or Obesity.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This study is testing a new study medicine to treat people living with overweight or obesity. The aim of this study is to see if the medicine is safe, how it works in human body, and what human body does to the study medicine. Participants will either get the new study medicine NNC0174-1213, a study medicine called cagrilintide or a placebo (a dummy medicine similar to the new study medicine and study medicine but without active ingredients). Which treatment participants will get is decided by chance. The new study medicine and the study medicine are potential new medicines which cannot be prescribed by doctors. This study will last for about a year in total.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Male.

• Age 18-55 years (both inclusive) at the time of signing the informed consent.

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

• Body weight more than or equal to (\>=) 80.0 kilograms (kg) at screening.

• 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.

Locations
United States
Texas
ICON Early Phase Services, LLC
RECRUITING
San Antonio
Utah
ICON Early Phase Services, LLC
RECRUITING
Salt Lake City
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2024-12-03
Estimated Completion Date: 2026-05-17
Participants
Target number of participants: 177
Treatments
Experimental: Part A: NNC0174-1213 (SD1-SD5)
Part A: Single ascending dose (SAD) of NNC0174-1213 will be administered in cohorts 1-5.
Experimental: Part A: Cagrilintide (SDA and SDB)
Part A: Single ascending dose (SAD): Cagrilintide SDA will be administered in cohort 1 and 2.~Cagrilintide SDB will be administered in cohort 3 and 4.
Experimental: Part A: Placebo
Part A: Single ascending dose (SAD) of placebo will be administered to cohorts 1-5.
Experimental: Part B: NNC0174-1213 (MD1-MD5)
Part B: Multiple ascending doses (MAD) of NNC0174-1213 will be administered to cohorts 1-5.
Experimental: Part B: Cagrilintide (MDA)
Part B: Multiple ascending doses (MAD) of Cagrilintide MDA will be administered to cohorts 1-5.
Experimental: Part B: Placebo
Part B: Multiple ascending doses (MAD) of placebo will be administered to cohorts 1-5.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov