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Type 2 DiabetesPhase 2NCT06118008

A Study of HS-20094 in T2DM Participants

A Phase 2 study testing HS-20094 5mg, HS-20094 10mg and HS-20094 15mg in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
HS-20094 5mg, HS-20094 10mg and HS-20094 15mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteChina
Study dates
31 May 2023to 4 Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects,20-65 years of age at the time of signing informed consent.
  • Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
  • Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.

Who cannot join

  • A history of type 1 diabetes, specific diabetes, or secondary diabetes.
  • Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
  • Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.
  • A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or 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.
  • Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
  • Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
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  • Uncontrollable hypertension.
  • History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
  • Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
  • Pregnant or lactating woman.
  • In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Multiple-dose, Randomized, Double-blind, Placebo and Positive Controlled Phase IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-20094 in Subjects With Type 2 Diabetes.

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.

Conditions
Type 2 Diabetes
Being tested
HS-20094 5mg, HS-20094 10mg, HS-20094 15mg, HS-20094 20mg
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20094 5mgDrug

    Also called HS-20094 injection 5mg

    Administrated by subcutaneous injection

  • HS-20094 10mgDrug

    Also called HS-20094 injection 10mg

    Administrated by subcutaneous injection

  • HS-20094 15mgDrug

    Also called HS-20094 injection 15mg

    Administrated by subcutaneous injection

  • HS-20094 20mgDrug

    Also called HS-20094 injection 20mg

    Administrated by subcutaneous injection

Study groups in NCT06118008
Study groupRoleWhat they receive
HS-20094 5mgExperimentalDrug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
Receives: Drug: HS-20094 5mg
HS-20094 10mgExperimentalDrug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
Receives: Drug: HS-20094 10mg
HS-20094 15mgExperimentalDrug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
Receives: Drug: HS-20094 15mg
HS-20094 20mgExperimentalDrug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection
Receives: Drug: HS-20094 20mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug

    A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module

    Measured: From Baseline to Day 57.

  2. The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function

    Measured: From Baseline to Day 57

  3. The changes ECG examination assessed by PR, R-R, QRS and QTcF

    12-lead electrocardiogram (ECG) parameters

    Measured: From Baseline to Day 57

  4. The changes in Blood pressure

    Vital signs

    Measured: From Baseline to Day 57

  5. Pulse rate

    Vital signs

    Measured: From Baseline to Day 57

  6. Respiratory rate

    Vital signs

    Measured: From Baseline to Day 57

  7. Temperature

    Vital signs

    Measured: From Baseline to Day 57

Secondary outcomes (4)

  1. Pharmacokinetics (PK): Cmax of HS-20094

    PK: Cmax of HS-20094

    Measured: Baseline to Day 57

  2. Pharmacokinetics (PK): Tmax of HS-20094

    PK: Tmax of HS-20094

    Measured: Baseline to Day 57

  3. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094

    PK: AUC of HS-20094

    Measured: Baseline to Day 57

  4. Pharmacodynamics (PD): HbA1c

    PD: change of HbA1c

    Measured: Baseline to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start31 May 2023
  3. Primary completion4 Jan 2024
  4. Study completion4 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118008
Sponsor's protocol ID
HS-20094-201
Status last verified
Jul 2025
First submitted
25 May 2023
Last updated
3 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-20094 5mg, HS-20094 10mg and HS-20094 15mg in people with Type 2 Diabetes, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug (time frame: From Baseline to Day 57.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118008.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.

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