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A Study of HS-20094 in Patients With T2DM
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
Lead sponsor
Assets
Dulaglutide / GLP-1 / incretin class catch-all
Listed sites
1
Recruiting sites
—
Enrollment
275
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥22•HbA1c 7-10.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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)
Endpoints (8)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsThe change in body weight
Time frame:From baseline to week 32
Body weight, absolute change (kg)
change from baseline, improvement
The percentage of patients with 5% or greater body weight loss
Time frame:From baseline to week 32
≥5% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
6 endpointsThe change of HbA1c in the patients
Time frame:From baseline to week 32
HbA1c, change
change from baseline, improvement
LOINC 4548-4
The percentage of patients reaching the HbA1c target of ≤ 6.5%
Time frame:From baseline to week 32
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
The percentage of patients reaching the HbA1c target of<7.0%
Time frame:From baseline to week 32
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
The change in fasting blood glucose
Time frame:From baseline to week 32
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
The change in C peptide
Time frame:From baseline to week 32
C-peptide AUC
change from baseline, improvement
The change of fasting insulin in the patients
Time frame:From baseline to week 32
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.