A Study of HS-20094 in Patients With T2DM

NCT06901648
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Phase
Phase 2
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Recruitment status
Completed
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Participants
275
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Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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Start date
2024-02-06
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Number of sites
1
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Summary
This is a 32-week, phase 2, randomized study, HS-20094 and placebo were double-blind, dulaglutide was open-label. Adults with T2D inadequately controlled with diet and exercise alone or with stable metformin, an HbA1c (glycated hemoglobin) ≥53 to ≤91 mmol/mol (≥7.0 % to≤10.5 %) were randomly assigned to receive 5 mg HS-20094, 10 mg HS-20094, 15 mg HS-20094, placebo, or 1.5 mg dulaglutide subcutaneously for 32 weeks. The primary endpoint was change in HbA1C from baseline to 32 weeks, and secondary endpoints included change in fasting glucose, body weight and several additional measures relevant for cardiovascular risks.
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Short title
A Study of HS-20094 in Patients With T2DM
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Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2025-04-09
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First posted
2025-03-30
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Registry last updated
2025-08-01
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Primary completion date
2025-03-07
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Start date
2024-02-06
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Actual participants
275
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Participants
275
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06901648
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ClinicalTrials.gov ID
NCT06901648
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. The change of HbA1c in the patients

    Timeframe: From baseline to week 32

  1. The percentage of patients reaching the HbA1c target of ≤ 6.5%

    Timeframe: From baseline to week 32

  2. The percentage of patients reaching the HbA1c target of<7.0%

    Timeframe: From baseline to week 32

  3. The change in fasting blood glucose

    Timeframe: From baseline to week 32

  4. The change in C peptide

    Timeframe: From baseline to week 32

  5. The change of fasting insulin in the patients

    Timeframe: From baseline to week 32

  6. The change in body weight

    Timeframe: From baseline to week 32

  7. The percentage of patients with 5% or greater body weight loss

    Timeframe: From baseline to week 32

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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.

  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)
Sources for eligibility
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  • Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)Tianjin, China
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)