Single and Multiple Ascending Dose Study of AMG 513 in Participants With Obesity

StatusCompleted
PhasePhase 1
SponsorAmgen
Started

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Record History

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  1. Trial completed
    • Primary and study completion dates changed from estimate of Sep 24, 2026 to Sep 16, 2026
    • Site details revised at 1 of 13 sites
    • Eligibility criteria expanded, about 4 words
  2. Enrollment closed, study ongoingv15 Show 4 more changesShow less
    • Trial sites expanded: 10 → 13 locations
    • Enrollment target: estimated 80 to confirmed 82
    • Primary and study completion dates: Oct 1, 2026 to Sep 24, 2026
    • Secondary endpoints: details revised at 3 of 3 entries
  3. Study sites: 9 to 10v14
  4. Study sites: 7 to 9v13
  5. Study sites: 5 to 7v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary and study completion dates: Jul 22, 2026 to Oct 1, 2026
    • Study sites revised (5)
    v11
  2. Primary and study completion dates: Jul 25, 2026 to Jul 22, 2026
    • Interventions: AMG 513 (Drug), Placebo (Drug) to AMG 513 (Drug), AMG 513 (Drug), Placebo (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 12 words
    v10
  3. Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 7 words
    • Site details revised at 5 of 5 sites
    v9
  4. Trial status: Suspended to Active, Not Recruiting
    • Site details revised at 1 of 5 sites
    v8
  5. Trial status: Recruiting to Suspended Sponsor's reason: In response to the request from the FDA
    • Site details revised at 5 of 5 sites
    v7
  6. Study sites: 4 to 5
    • Primary and study completion dates: Aug 15, 2026 to Jul 25, 2026
    v6
  7. Primary and study completion dates: Mar 5, 2026 to Aug 15, 2026
    • Site details revised at 1 of 4 sites
    v5
  8. Study sites: 3 to 4v4
  9. Re-verified, no change to tracked fieldsv3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary and study completion dates: Mar 17, 2026 to Mar 5, 2026
    • Start date changed from estimate of Sep 16, 2024 to Sep 9, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Amgen
169 trials monitored
See 11 trials at risk
The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.
Trial Details
NCT Number NCT06585462
Lead Sponsor Amgen
Conditions
(from sponsor)		 Cardiometabolic Disease
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov