Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-12

Study Completion Date

2024-09-24

Brief Summary

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To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment group A

HRS9531 injection dose level 1

Group Type EXPERIMENTAL

HRS9531 injection

Intervention Type DRUG

single dose

Treatment group B

HRS9531 injection dose level 2

Group Type EXPERIMENTAL

HRS9531 injection

Intervention Type DRUG

single dose

Treatment group C

HRS9531 injection dose level 3

Group Type EXPERIMENTAL

HRS9531 injection

Intervention Type DRUG

single dose

Treatment group D

HRS9531 injection dose level 4

Group Type EXPERIMENTAL

HRS9531 injection

Intervention Type DRUG

single dose

Treatment group E

HRS9531 injection Placebo dose level 1

Group Type PLACEBO_COMPARATOR

HRS9531 injection Placebo

Intervention Type DRUG

single dose

Treatment group F

HRS9531 injection Placebo dose level 2

Group Type PLACEBO_COMPARATOR

HRS9531 injection Placebo

Intervention Type DRUG

single dose

Treatment group G

HRS9531 injection Placebo dose level 3

Group Type PLACEBO_COMPARATOR

HRS9531 injection Placebo

Intervention Type DRUG

single dose

Treatment group H

HRS9531 injection Placebo dose level 4

Group Type PLACEBO_COMPARATOR

HRS9531 injection Placebo

Intervention Type DRUG

single dose

Interventions

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HRS9531 injection

single dose

Intervention Type DRUG

HRS9531 injection Placebo

single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent
2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.
3. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. HbA1c 7.5-10.5% (both inclusive) at screening visit.

Exclusion Criteria

1. Presence of any clinically significant results in examination at screening visit.
2. Uncontrollable hypertension.
3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.
4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
6. 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.
7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.
8. Surgery is planned during the trial.
9. Mentally incapacitated or speech-impaired.
10. Pregnant or lactating woman.
11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No