NCT06118008

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started May 2023

Shorter than P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2024

Completed
Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

May 25, 2023

Last Update Submit

July 30, 2025

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (7)

  • 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

    From Baseline to Day 57.

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

    From Baseline to Day 57

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

    12-lead electrocardiogram (ECG) parameters

    From Baseline to Day 57

  • The changes in Blood pressure

    Vital signs

    From Baseline to Day 57

  • Pulse rate

    Vital signs

    From Baseline to Day 57

  • Respiratory rate

    Vital signs

    From Baseline to Day 57

  • Temperature

    Vital signs

    From Baseline to Day 57

Secondary Outcomes (4)

  • Pharmacokinetics (PK): Cmax of HS-20094

    Baseline to Day 57

  • Pharmacokinetics (PK): Tmax of HS-20094

    Baseline to Day 57

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

    Baseline to Day 57

  • Pharmacodynamics (PD): HbA1c

    Baseline to Day 29

Study Arms (4)

HS-20094 5mg

EXPERIMENTAL

Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection

Drug: HS-20094 5mg

HS-20094 10mg

EXPERIMENTAL

Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection

Drug: HS-20094 10mg

HS-20094 15mg

EXPERIMENTAL

Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection

Drug: HS-20094 15mg

HS-20094 20mg

EXPERIMENTAL

Drug: HS-20094 Administrated by subcutaneous injection Drug: Placebo Administrated by subcutaneous injection Drug: Semaglutide Administrated by subcutaneous injection

Drug: HS-20094 20mg

Interventions

HS-20094 5mgDRUG

Administrated by subcutaneous injection

Also known as: HS-20094 injection 5mg
HS-20094 5mg
HS-20094 10mgDRUG

Administrated by subcutaneous injection

Also known as: HS-20094 injection 10mg
HS-20094 10mg
HS-20094 15mgDRUG

Administrated by subcutaneous injection

Also known as: HS-20094 injection 15mg
HS-20094 15mg
HS-20094 20mgDRUG

Administrated by subcutaneous injection

Also known as: HS-20094 injection 20mg
HS-20094 20mg

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

November 7, 2023

Study Start

May 31, 2023

Primary Completion

January 4, 2024

Study Completion

January 4, 2024

Last Updated

August 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)