NCT05159882 is a Phase 3 clinical trial of THR-1442 and Dapagliflozin placebo in T2DM, sponsored by Newsoara Biopharma Co., Ltd..

Who is sponsoring NCT05159882?

NCT05159882 is sponsored by Newsoara Biopharma Co., Ltd..

What drugs are being tested in NCT05159882?

Interventions in NCT05159882: THR-1442 and Dapagliflozin placebo, Dapagliflozin 10mg and THR1442 placebo.

Is NCT05159882 still recruiting?

NCT05159882 is currently status unknown. Last updated 16 December 2021.

Last reviewed 2021-12-16 · How we verify

NCT05159882

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 3 Last updated 16 December 2021

What this trial tests

Phase 3 trial testing THR-1442 and Dapagliflozin placebo in T2DM in 390 participants. Status unknown.

Timeline

15 April 2021

Primary endpoint
30 September 2022

30 September 2022

Quick facts

Lead sponsor	Newsoara Biopharma Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	390
Start date	15 April 2021
Primary completion	30 September 2022
Estimated completion	30 September 2022
Sites	6 locations across China

Drugs / interventions tested

THR-1442 and Dapagliflozin placebo — full drug profile →
Dapagliflozin 10mg and THR1442 placebo — full drug profile →

Conditions studied

T2DM — all drugs for T2DM →

Sponsor

Newsoara Biopharma Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with T2DM. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to investigate the effect of THR-1442 compared to Dapagliflozin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Efficacy and safety of bexagliflozin compared with dapagliflozin as an adjunct to metformin in Chinese patients with type 2 diabetes mellitus: A 24-week, randomized, double-blind, active-controlled, phase 3 trial.
Xie L, Han J, Cheng Z, Liu D, et al · · 2024 · cited 4× · PMID 38584148 · DOI 10.1111/1753-0407.13526
Bexagliflozin as an Adjunct Therapy to Diet and Exercise to Improve Glycaemic Control in Adults with Type 2 Diabetes.
Stachteas P, Patoulias D, Popovic DS, Athanasiadou P, et al · · 2024 · cited 1× · PMID 38812664 · DOI 10.17925/ee.2024.20.1.6

Verify or expand the search:

Other recruiting trials for T2DM

Currently open trials in the same condition.

NCT07347080 — A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) · EARLY_PHASE1 · recruiting
NCT07005362 — Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D · recruiting
NCT07019012 — Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients Wi · Phase 4 · recruiting
NCT06942195 — Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes · NA · recruiting
NCT06686134 — Comprehensive Clinical Evaluation Study of GLP-1RA · recruiting

Other Newsoara Biopharma Co., Ltd. trials

Trials by the same sponsor.

NCT06218940 — HY1272 in Patients With Locally Advanced or Metastatic Solid Tumors or Locally Advanced or Metastatic EGFRm+ NSCLC · Phase 1 · not yet recruiting
NCT06584058 — HPP737 Substance Balance Study in Human · NA · not yet recruiting
NCT05369078 — Safety, Tolerance and Pharmacokinetics of THR-1442 in Chinese Healthy Subjects · Phase 1 · unknown
NCT04714294 — Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers · Phase 1 · unknown
NCT05056935 — Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05159882 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Newsoara Biopharma Co., Ltd.
Last refreshed: 16 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05159882.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing