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

Part of paid clinical trials in San Antonio, Texas.

Sponsor
Novo Nordisk A/S
Study ID
NCT06719011
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • NNC0174-1213 A — DRUG
    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 — DRUG
    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) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
May 2025
Primary completion
Mar 26, 2026
Completion
May 17, 2026

Study Design

Enrollment
177 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Part A: Number of treatment emergent adverse events (TEAE) reported by participants exposed to NNC0174 1213 [ Time Frame: From NNC0174 1213 administration (Day 1) to completion of the end of study visit (Day 46) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
ICON Early Phase Services, LLCSan AntonioTexas78209-
ICON Early Phase Services, LLCSalt Lake CityUtah84124-

Find similar trials in San Antonio, TX

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
ICON Early Phase Services, LLC· San Antonio, TXICON Early Phase Services, LLC· Salt Lake City, UT

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