RecruitingPhase 1NCT06719011

A Study on How NNC0174-1213 Works in People With Overweight or Obesity.

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.

Sponsor

Novo Nordisk A/S

Enrollment

177 participants

Start Date

Dec 3, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Overweight

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

Sex: MALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cagrilintide B, a drug called NNC0174-1213 A, and others for people with obesity and overweight. The study is currently recruiting participants at 2 locations. People eligible for this study include men aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNNC0174-1213 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.

DRUGCagrilintide 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.

DRUGPlacebo 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

View Full Details on ClinicalTrials.gov

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NCT06719011

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