deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT03496298

Effect of Efpeglenatide on Cardiovascular Outcomes (AMPLITUDE-O)

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of Efpeglenatide on Cardiovascular Outcomes in Type 2 Diabetes Patients at High Cardiovascular Risk

Sponsor: Hanmi Pharmaceutical Company Limited

Conditions Type 2 Diabetes Mellitus
Interventions Efpeglenatide (SAR439977) Placebo
Updated 34 times since 2018 Last updated: Sep 16, 2021 Started: Apr 27, 2018 Primary completion: Dec 10, 2020 Completion: Dec 10, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision to cancel TRIAL, not related to safety concern

Other terminated trials from Hanmi Pharmaceutical Company Limited

More terminations from Hanmi Pharmaceutical Company Limited

Other Type 2 Diabetes Mellitus trials with similar outcome

Browse all Type 2 Diabetes Mellitus trials

Listed as NCT03496298, this PHASE3 trial focuses on Type 2 Diabetes Mellitus and remains terminated or withdrawn. Sponsored by Hanmi Pharmaceutical Company Limited, it has been updated 34 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Sep 2018 · 31 days · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Jun 2020 · 2 months · monthly snapshot~Jun 2020 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Nov 2021 · 9 months · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Mar 2026 · 4 months · monthly snapshot~Mar 2026 – present · 5 months · monthly snapshot

Change History

34 versions recorded

  1. Mar 2026 — Present [monthly]

    Terminated PHASE3

  2. Nov 2025 — Mar 2026 [monthly]

    Terminated PHASE3

  3. Sep 2025 — Nov 2025 [monthly]

    Terminated PHASE3

  4. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

▶ Show 29 earlier versions

  1. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  2. Nov 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  3. Feb 2021 — Nov 2021 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  4. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  7. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  8. Apr 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  11. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE3

  12. Nov 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  13. Oct 2019 — Nov 2019 [monthly]

    Active Not Recruiting PHASE3

  14. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  15. Jul 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  16. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  17. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  18. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  19. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  20. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  21. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  22. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  23. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  24. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  25. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  26. Aug 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  27. Jul 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  28. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  29. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Apr 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hanmi Pharmaceutical Company Limited
  • Sanofi
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus N, Denmark , Actopan, Mexico , Adana, Turkey (Türkiye) , Aguascalientes, Mexico , Alcorcón, Spain , Alexandria, United States , Ankara, Turkey (Türkiye) , Antalya, Turkey (Türkiye) , Antofagasta, Chile , Arlington Heights, United States and 255 more locations