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

A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: HRS9531; Drug: Placebo; Drug: Dulaglutide Injection

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Zhongshan Hospital Affiliated to Fudan University
      • Principal Investigator: Xuening Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection	Drug: HRS9531; Administrated SC; Drug: Placebo; Administrated SC
EXPERIMENTAL: Group B; Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection	Drug: HRS9531; Administrated SC; Drug: Placebo; Administrated SC
EXPERIMENTAL: Group C; Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection	Drug: HRS9531; Administrated SC; Drug: Placebo; Administrated SC
ACTIVE_COMPARATOR: Group D; Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection	Drug: Dulaglutide Injection; Administrated SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Immunogenicity: anti-HRS9531 antibody	Start of Treatment up to Day 62

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2022
• Primary Completion (ANTICIPATED): March 29, 2023
• Study Completion (ANTICIPATED): May 3, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide
• Other Study ID Numbers: HRS9531-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No