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NCT06745284

A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 16 versions: 16 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 13 words
    • Primary completion moved earlier from Jan 8, 2027 to Nov 1, 2026
    • Study completion moved earlier from Jan 10, 2027 to Dec 1, 2026
  2. Study completion date: Jan 8, 2027 to Jan 10, 2027v15
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 60 to confirmed 64
    • Study sites revised (2)
    v14
  4. Primary and study completion dates: Jan 10, 2027 to Jan 8, 2027v13
  5. Primary and study completion dates pushed to Jan 10, 2027v12
Show 10 earlier versionsHide 10 earlier versions
  1. Start date: Apr 8, 2025 to Mar 26, 2025v11
  2. Start date: Apr 18, 2025 to Apr 8, 2025v10
  3. Site details revised at 1 of 2 sitesv9
  4. Start date: Mar 26, 2025 to Apr 18, 2025v8
  5. Study sites revised (2)v7
  6. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary endpoint revised
    • Start date changed from estimate of Mar 28, 2025 to Mar 26, 2025
    • Secondary endpoints revised (3)
    • Site details revised at 2 of 2 sites
  7. Start date: Mar 19, 2025 to Mar 28, 2025v5
  8. Start date: Feb 28, 2025 to Mar 19, 2025v4
  9. Start date: Jan 17, 2025 to Feb 28, 2025v3
  10. Study sites: 0 to 2v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Timeframe: at baseline, up to 36 weeks

Secondary (3)

Relative change in SMR (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Absolute change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Relative change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss

Arms and interventions

Survodutide armExperimental
Semaglutide armActive comparator

Drugs: Survodutide, Semaglutide

Sites

2 sites in 1 country