Current partner codePEPTIDESDE
NCT06901648·Phase 2·INTERVENTIONAL

A Study of HS-20094 in Patients With T2DM

Status

Completed

Phase

Phase 2

Enrollment

275

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

HS-20094

Administrated by subcutaneous injection once a week

DRUG

Dulaglutide

Administrated by subcutaneous injection once a week

DRUG

Palcebo

Administrated by subcutaneous injection once a week

Timeline

From registration to results.

  1. First posted

    Mar 30, 2025

  2. Study start

    Feb 6, 2024

  3. Primary completion

    Mar 7, 2025

  4. Study completion

    Apr 9, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Aug 1, 2025

Outcomes

What the study measures.

Primary outcomes

The change of HbA1c in the patients

Time frame · From baseline to week 32

Secondary outcomes

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

Time frame · From baseline to week 32

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

Time frame · From baseline to week 32

The change in fasting blood glucose

Time frame · From baseline to week 32

The change in C peptide

Time frame · From baseline to week 32

The change of fasting insulin in the patients

Time frame · From baseline to week 32

The change in body weight

Time frame · From baseline to week 32

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

Time frame · From baseline to week 32

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
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)

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Tianjin Medical University General Hospital (Zhu Xianyi Memorial Hospital)

Tianjin, Tianjin Municipality, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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