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NCT06577766

A Research Study on How NNC0638-0355, a New Medicine, Works in People Living With Overweight or Obesity

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 12 months later.

See at-risk trials from Novo Nordisk

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Record History

All 8 versions: 7 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Primary and study completion pushed from Sep 24, 2026 to Oct 11, 2027
    • Trial sites expanded: 1 → 4 locations
    v7
  3. Primary completion date: Mar 23, 2026 to Sep 24, 2026
    • Primary endpoints revised (2)
    • Enrollment target: estimated 88 to confirmed 63
    • Secondary endpoints: 5 to 4
    v6
  4. Primary completion date: Sep 23, 2025 to Mar 23, 2026
    • Study completion date: Nov 18, 2025 to Sep 24, 2026
    • Start date: Sep 2, 2024 to Sep 3, 2024
    v5
  5. Trial status: Recruiting to Active, Not Recruitingv4 Show 4 more changesShow less
    • Study sites: 2 to 1
    • Primary completion date changed from estimate of Sep 18, 2025 to Sep 23, 2025
    • Study completion date: Sep 18, 2025 to Nov 18, 2025
    • Start date: Sep 3, 2024 to Sep 2, 2024
  6. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part A: Number of treatment emergent adverse events (TEAE)
Timeframe: From NNC0638-0355 administration (day 1) to completion of the end of study visit (6 weeks)
Part B,C,D and E : Number of treatment emergent adverse events (TEAE)
Timeframe: From first NNC0638-0355 administration (day 1) to completion of the end of study visit (20 weeks)

Secondary (4)

Part A: AUC; area under the NNC0638-0355 plasma concentration-time curve
Part A: Cmax; maximum observed NNC0638-0355 plasma concentration
Part B,C,D and E: AUC; area under the NNC0638-0355 plasma concentration-time curve
Part B,C,D and E: Cmax; maximum observed NNC0638-0355 plasma concentration

Arms and interventions

NNC0638-0355Experimental

Participants will be randomized to receive NNC0638-0355. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD) Part B, C, D and E: Multiple ascending dose (MAD).

PlaceboPlacebo comparator

Participants will be randomized to receive Placebo. The study will be conducted in 5 parts. Part A: Single ascending dose (SAD). Part B, C,D and E: Multiple ascending dose (MAD).

Drugs: NNC0638-0355, Placebo (NNC0638-0355)

Sites

4 sites in 2 countries

United States 3, Netherlands 1