Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Study acronym: KaiNETIC-2
StatusActive, Not Recruiting
PhasePhase 3
SponsorKailera
Started

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Record History

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  1. Minor Enrollment closed, study ongoing Show 4 more changesShow less
    • Trial sites expanded: 167 → 173 locations
    • Enrollment target: estimated 1156 to confirmed 1270
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 3 of 33 entries
  2. Minor Trial sites expanded: 163 → 167 locations
    • Trial sites expanded: 116 → 163 locations
    v21
  3. Minor Study sites: 116 to 163v20
  4. Notable Primary endpoint(s) modifiedv19 Show 6 more changesShow less
    • Enrollment reduced: 1700 → 1156 participants
    • Trial sites expanded: 58 → 116 locations
    • Interventions: KAI-9531 (Drug), Placebo (Drug) to Placebo (Drug), Ribupatide (Drug)
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints revised (33)
    • Study title revised
  5. Minor Trial sites expanded: 52 → 58 locationsv18
  6. Minor Trial sites expanded: 49 → 52 locationsv17
  7. Minor Study sites: 48 to 49v16
  8. Minor Study sites: 46 to 48v15
  9. Minor Study sites: 44 to 46v14
  10. Minor Trial sites expanded: 37 → 44 locationsv13
  11. Minor Trial sites expanded: 30 → 36 locationsv12
  12. Minor Study sites: 30 to 36v11
  13. Minor Trial sites expanded: 27 → 30 locationsv10
  14. Minor Trial sites expanded: 24 → 27 locationsv9
  15. Minor Study sites: 21 to 24v8
  16. Minor Study sites: 20 to 21v7
  17. Minor Study sites: 16 to 20v6
  18. Minor Study sites: 12 to 16v5
  19. Minor Study sites: 7 to 12v4
  20. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 7
    • Start date changed from estimate of Dec 2025 to Jan 12, 2026
    v3
  21. Minor Re-verified, no change to tracked fieldsv2
  22. 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.
7 trials monitored
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5,101 trials monitored
See 233 trials at risk
3,888 trials monitored
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The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
Trial Details
NCT Number NCT07284901
Lead Sponsor Kailera
Conditions
(from sponsor)
Obesity With Diabetes, Overweight With Diabetes
Related terms Diabetes Mellitus, Obesity, Overweight
Enrollment 1,270 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov