Testing HS-20094 for managing Type 2 Diabetes

Efficacy and Safety of HS-20094, a Novel Dual GIP and GLP-1 Receptor Agonist, in Patients With Type 2 Diabetes: a Randomized, Placebo-controlled and Active Comparator-controlled Phase 2 Trial

This study is testing a new medication called HS-20094 to see if it can help adults with Type 2 Diabetes better control their blood sugar and possibly lose weight compared to standard treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT06901648 on ClinicalTrials.gov

What this trial studies

This is a 32-week, phase 2, randomized, double-blind study evaluating the efficacy of HS-20094 in adults with inadequately controlled Type 2 Diabetes (T2D). Participants will be assigned to receive either HS-20094 at varying doses, a placebo, or an open-label treatment of dulaglutide. The primary goal is to assess the change in HbA1c levels from baseline to the end of the study, with secondary outcomes including changes in fasting glucose and body weight, as well as cardiovascular risk factors. The study aims to provide insights into the effectiveness of HS-20094 compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with Type 2 Diabetes inadequately managed by diet, exercise, or stable metformin therapy.

Not a fit: Patients with Type 1 diabetes, gestational diabetes, or other specific types of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new option for patients struggling to control their Type 2 Diabetes.

How similar studies have performed: Previous studies have shown promise in similar approaches for managing Type 2 Diabetes, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients 18 to 75 years of age, inclusive
2. Patients were diagnosed with T2DM for at least 3 months before screening.
3. Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
4. Body mass index (BMI）≥ 22 kg/m2.

Exclusion Criteria:

1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
3. A history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening
4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
5. Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)

Where this trial is running

Tianjin, Tianjin

• Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital) — Tianjin, Tianjin, China (Recruiting)

Study contacts

• Study coordinator: li

Conditions Type 2 Diabetes