deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT05159882

Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM

A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase III Study on Metformin Combined With THR-1442 or Dapagliflozin in T2DM

Sponsor: Newsoara Biopharma Co., Ltd.

Conditions T2DM
Interventions Dapagliflozin 10mg and THR1442 placebo THR-1442 and Dapagliflozin placebo
Updated 6 times since 2022 Last updated: Dec 3, 2021 Started: Apr 15, 2021 Primary completion: Sep 30, 2022 Completion: Sep 30, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05159882, this PHASE3 trial focuses on T2DM and remains ongoing. Sponsored by Newsoara Biopharma Co., Ltd., it has been updated 6 times since 2021, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2022 – ~Dec 2023 · 23 months · monthly snapshotRecruiting~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Dec 2025 · 15 months · monthly snapshotUnknown~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshotUnknown~Jan 2026 – present · 6 months · monthly snapshotUnknown

Change History

6 versions recorded

  1. Jan 2026 — Present [monthly]

    Unknown PHASE3

  2. Dec 2025 — Jan 2026 [monthly]

    Unknown PHASE3

  3. Sep 2024 — Dec 2025 [monthly]

    Unknown PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE3

    Status: Unknown Status → Unknown

  5. Dec 2023 — Jul 2024 [monthly]

    Unknown Status PHASE3

    Status: Recruiting → Unknown Status

▶ Show 1 earlier version

  1. Jan 2022 — Dec 2023 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2021

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Newsoara Biopharma Co., Ltd.
Data source: Newsoara HYK Biopharmaceutical (Shanghai) Co., Ltd.

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

Study Locations