A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Minor Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Sep 24, 2026 to Sep 30, 2026
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints: details revised at 3 of 24 entries
    • Site details revised at 3 of 70 sites
  2. Minor Enrollment increased: 360 → 447 participants
    • Primary completion date changed from estimate of Jun 1, 2026 to May 29, 2026
    v22
  3. Minor Primary completion moved earlier from Aug 10, 2026 to Jun 1, 2026
    • Study completion moved earlier from Nov 30, 2026 to Sep 24, 2026
    • Interventions: CT-388 (Drug), Placebo (Drug) to Enicepatide (Drug), Placebo (Drug)
    • Study title expanded, about 1 word
    v21
  4. Minor Re-verified, no change to tracked fieldsv20
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 85 to 70
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Study sites: 84 to 85v18
  2. Minor Study sites: 79 to 84v17
  3. Minor Study sites: 67 to 79v16
  4. Minor Study sites: 58 to 67v15
  5. Minor Study sites: 57 to 58v14
  6. Notable Primary endpoints revised (2)v13 Show 5 more changesShow less
    • Study sites: 43 to 57
    • Primary completion date: May 31, 2026 to Aug 10, 2026
    • Study completion date: May 31, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 92 words
    • Secondary endpoints: 22 to 24
  7. Minor Study sites: 41 to 43v12
  8. Minor Study sites: 38 to 41v11
  9. Minor Study sites: 33 to 38v10
  10. Minor Study sites: 32 to 33v9
  11. Minor Study sites: 30 to 32v8
  12. Minor Study sites: 26 to 30v7
  13. Minor Site details revised at 1 of 26 sitesv6
  14. Minor Study sites: 12 to 26
    • Start date changed from estimate of Nov 30, 2024 to Nov 21, 2024
    v5
  15. Notable Start date: Oct 30, 2024 to Nov 30, 2024
    • Study sites: 3 to 12
    v4
  16. Minor Study sites: 1 to 3v3
  17. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).
Trial Details
NCT Number NCT06628362
Lead Sponsor Carmot Therapeutics, Inc.
Collaborators: Hoffmann-La Roche
Conditions
(from sponsor)
Overweight or Obese, Type 2 Diabetes Mellitus (T2DM)
Related terms Diabetes Mellitus, Type 2, Obesity, Overweight
Enrollment 447 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov