Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

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

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-05-24

Brief Summary

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The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus 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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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

HRS9531 injection compared with placebo and open positive-controlled group

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Group Type EXPERIMENTAL

HRS9531

Intervention Type DRUG

Administrated SC

Placebo

Intervention Type DRUG

Administrated SC

Group B

Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Group Type EXPERIMENTAL

HRS9531

Intervention Type DRUG

Administrated SC

Placebo

Intervention Type DRUG

Administrated SC

Group C

Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection

Group Type EXPERIMENTAL

HRS9531

Intervention Type DRUG

Administrated SC

Placebo

Intervention Type DRUG

Administrated SC

Group D

Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection

Group Type ACTIVE_COMPARATOR

Dulaglutide Injection

Intervention Type DRUG

Administrated SC

Interventions

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HRS9531

Administrated SC

Intervention Type DRUG

Placebo

Administrated SC

Intervention Type DRUG

Dulaglutide Injection

Administrated SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
3. Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
4. 7.0% ≤ HbA1c ≤10.5% at screening.

Exclusion Criteria

1. History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
2. Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
3. Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) or episode of severe hypoglycaemic events within 12 months prior to screening.
4. Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
5. Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
6. Breast-feeding women.
7. The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No