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

NCT05516966 | Completed Phase 1

• 1 other identifier: HRS9531-102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (Safety and Tolerability)

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

  Screening period up to Day 62

Secondary Outcomes (6)

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

  Start of Treatment up to Day 62

• Maximum Concentration (Cmax) of HRS9531

  Start of Treatment up to Day 62

• Change from Baseline in Fasting Blood Glucose (FBG)

  Baseline up to Day 62

• Change from Baseline in Hemoglobin A1c (HbA1c)

  Baseline up to Day 29

• Change from Baseline in Weight

  Baseline up to Day 62

Study Arms (4)

Group A

EXPERIMENTAL

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

Drug: HRS9531; Drug: Placebo

Group B

EXPERIMENTAL

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

Drug: HRS9531; Drug: Placebo

Group C

EXPERIMENTAL

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

Drug: HRS9531; Drug: Placebo

Group D

ACTIVE COMPARATOR

Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection

Drug: Dulaglutide Injection

Interventions

HRS9531 DRUG

Administrated SC

Group A; Group B; Group C

Placebo DRUG

Administrated SC

Group A; Group B; Group C

Dulaglutide Injection DRUG

Administrated SC

Group D

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
• 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.
• Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
• Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
• Breast-feeding women.
• The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS9531 injection compared with placebo and open positive-controlled group

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: October 12, 2022
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (1)