Current partner codePEPTIDESDE
NCT05516966·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

64

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

HRS9531

Administrated SC

DRUG

Placebo

Administrated SC

DRUG

Dulaglutide Injection

Administrated SC

Timeline

From registration to results.

  1. First posted

    Aug 26, 2022

  2. Study start

    Oct 12, 2022

  3. Primary completion

    May 24, 2023

  4. Study completion

    May 24, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Nov 15, 2024

Outcomes

What the study measures.

Primary outcomes

Incidence of Adverse Events (Safety and Tolerability)

Time frame · Screening period up to Day 62

A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events

Secondary outcomes

Area Under the Concentration Versus Time Curve (AUC) of HRS9531

Time frame · Start of Treatment up to Day 62

Maximum Concentration (Cmax) of HRS9531

Time frame · Start of Treatment up to Day 62

Change from Baseline in Fasting Blood Glucose (FBG)

Time frame · Baseline up to Day 62

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame · Baseline up to Day 29

Change from Baseline in Weight

Time frame · Baseline up to Day 62

Immunogenicity: anti-HRS9531 antibody

Time frame · Start of Treatment up to Day 62

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

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

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai 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.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.