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NCT07156539Not yet recruitingPhase 3

A Phase 3 Study of HS-20094 in Patients With T2DM

A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete

Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
546 (estimated)
First submitted
28 Aug 2025
Start date
30 Sept 2025
Primary completion date
30 Mar 2027
Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT number
NCT07156539

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 546
  • From 30 Sept 2025 to the primary completion date, 30 Mar 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe infection, severe trauma, or moderate-to-major surgery within 4 weeks before screening.
  • Participated in clinical trials of any drug or medical device within 12 weeks prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).

Other illness

  • Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
  • Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
  • History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
  • Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ;

Who the study is looking for

  • Males and females, Age ≥18 years at the time of signing informed consent.
  • Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;
  • Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
  • BMI ≥ 23 kg/m2.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shandong Provincial Hospital
Coordinator of this site? Confirm its status
JinanChinaUnknown status
Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)
Coordinator of this site? Confirm its status
TianjinChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.