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A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
Sponsor: Novo Nordisk A/S
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.
Official title: 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.
Key Details
Gender
MALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
177
Start Date
2024-12-03
Completion Date
2026-05-17
Last Updated
2025-05-25
Healthy Volunteers
No
Conditions
Interventions
NNC0174-1213 A
Participants will be randomized to receive NNC0174-1213 A administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Cagrilintide B
Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Placebo A (NNC0174 1213 A)
Participants will be randomized to receive Placebo administered as subcutaneous (s.c. under the skin) injection. Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Locations (2)
ICON Early Phase Services, LLC
San Antonio, Texas, United States
ICON Early Phase Services, LLC
Salt Lake City, Utah, United States