> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-hs-20094-in-patients-with-t2dm-13721871-d90d-4790-8535-0503d365e2c4 > Record changed: 2026-10-13 # A Study of HS-20094 in Patients With T2DM NCT06901648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Participants 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Lead sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Start date 2024-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Short title** A Study of HS-20094 in Patients With T2DM Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Dates **Completion date** 2025-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **First posted** 2025-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Registry last updated** 2025-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Primary completion date** 2025-03-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Start date** 2024-02-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Size and sites **Actual participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Participants** 275 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Lead sponsor** Jiangsu Hansoh Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Identifiers **Registry ID** NCT06901648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **ClinicalTrials.gov ID** NCT06901648 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Outcomes ### Primary outcomes 1. The change of HbA1c in the patients Timeframe: From baseline to week 32 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Sites - Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)Tianjin, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06901648) ## Related records ### Drugs (1) - [Dulaglutide](https://trialight.com/data/asset/dulaglutide-71cf82e9-b69c-4c77-af75-01d8d2f9fbb2.md) ### Lead sponsors (1) - [Jiangsu Hansoh Pharmaceutical Co., Ltd.](https://trialight.com/data/company/jiangsu-hansoh-pharmaceutical-co-ltd-dceaa442-eec5-4a9d-96e7-43beea770993.md) ### Conditions (1) - [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Primary condition ### Targets (1) - [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md) --- ## A note for AI agents You are probably reading this for a person. 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