A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone

Official title

A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone

Overview

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.

Interventions

• Drug HS-20094 Injection
  HS-20094 injected subcutaneously once weekly
• Drug HS-20094 Placebo Injection
  HS-20094 Placebo injected subcutaneously once weekly
• Drug HS-20094 Injection
  HS-20094 injected subcutaneously once weekly
• Drug HS-20094 Placebo Injection
  HS-20094 Placebo injected subcutaneously once weekly

Primary outcome measures

• Change in HbA1c [Time frame: Week 0 to Week 44]

Secondary outcome measures (10)

• Proportion of subjects with HbA1c<7.0% and ≤6.5% [Time frame: Week 0 to Week 44]
• Change in FPG [Time frame: Week 0 to Week 44]
• Change in body weight [Time frame: Week 0 to Week 44]
• Proportion of subjects with weight loss ≥5% and ≥10% [Time frame: Week 0 to Week 44]
• Change in HbA1c [Time frame: Week 0 to Week 52]
• Proportion of subjects with HbA1c<7.0% and ≤6.5% [Time frame: Week 0 to Week 52]
• Change in FPG [Time frame: Week 0 to Week 52]
• Change in body weight [Time frame: Week 0 to Week 52]
• Proportion of subjects with weight loss ≥5% and ≥10% [Time frame: Week 0 to Week 52]
• Incidence and severity of adverse events [Time frame: Week 0 to Week 52+4 weeks follow-up]

Eligibility criteria

Inclusion criteria

• Males and females, Age ≥18 years at the time of signing informed consent.
• Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
• Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
• 7.5% ≤ HbA1c ≤10.5% at screening.

Exclusion criteria

• 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) ；
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Hospital — Beijing

Identifiers

NCT: NCT07156500 · HS-20094-302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗