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

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT05516966
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • HRS9531 — DRUG
    Administrated SC
  • Placebo — DRUG
    Administrated SC
  • Dulaglutide Injection — DRUG
    Administrated SC

Study Details

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.

Key Dates

Start date
Oct 12, 2022
Status verified
Nov 2024
Primary completion
May 24, 2023
Completion
May 24, 2023

Study Design

Enrollment
64 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A
    Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
  • Experimental: Group B
    Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
  • Experimental: Group C
    Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
  • Active Comparator: Group D
    Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection

Primary Outcome Measure

Incidence of Adverse Events (Safety and Tolerability) [ Time Frame: Screening period up to Day 62 ]

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