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Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05966272
Collaborator
(none)
180
Enrollment
8
Arms
13.3
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection versus placebo in controlling blood glucose after 20 weeks of treatment in subjects with type 2 diabetes who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

Condition or Disease Intervention/Treatment Phase
  • Drug: HRS9531 injection
  • Drug: HRS9531 injection Placebo
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical studyA multi-center, randomized, double-blind, placebo- parallel controlled Phase II clinical study
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Aug 12, 2024
Anticipated Study Completion Date :
Sep 9, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment group A

HRS9531 injection dose level 1

Drug: HRS9531 injection
single dose
Experimental: Treatment group B

HRS9531 injection dose level 2

Drug: HRS9531 injection
single dose
Experimental: Treatment group C

HRS9531 injection dose level 3

Drug: HRS9531 injection
single dose
Experimental: Treatment group D

HRS9531 injection dose level 4

Drug: HRS9531 injection
single dose
Placebo Comparator: Treatment group E

HRS9531 injection Placebo dose level 1

Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group F

HRS9531 injection Placebo dose level 2

Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group G

HRS9531 injection Placebo dose level 3

Drug: HRS9531 injection Placebo
single dose
Placebo Comparator: Treatment group H

HRS9531 injection Placebo dose level 4

Drug: HRS9531 injection Placebo
single dose

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in HbA1c after 20 weeks of treatment [Week 0 to Week 20]

Secondary Outcome Measures

  1. Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 20 weeks of treatment [Week 0 to Week 20]

  2. Proportion of subjects reaching HbA1c targets (HbA1c<7.0%) after 32 weeks of treatment [Week 0 to Week 32]

  3. Change From Baseline in HbA1c after 32 weeks [Week 0 to Week 32]

  4. Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 20 weeks of treatment [Week 0 to Week 20]

  5. Change from baseline in fasting plasma glucose (FPG), serum insulin and C-peptide after 32 weeks of treatment [Week 0 to Week 32]

  6. Change from baseline body Weight and waist circumference after 20 weeks of treatment [Week 0 to Week 20]

  7. Change from baseline in body Weight and waist circumference after 32 weeks of treatment [Week 0 to Week 32]

  8. Number of Participants With Anti-HRS9531 Antibody [Week 0 to Week 36]

  9. Number of AEs During the Trial [Week 0 to Week 36]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Male or female subjects ,18-65 years of age, agreed and signed the informed consent

  2. Type 2 diabetes mellitus diagnosed for at least 6 months before the screening visit.

  3. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.

  4. HbA1c 7.5-10.5% (both inclusive) at screening visit.

Exclusion Criteria:

  1. Presence of any clinically significant results in examination at screening visit.

  2. Uncontrollable hypertension.

  3. A history of type 1 diabetes, specific diabetes, or secondary diabetes.

  4. Acute diabetic complications or severe hypoglycemia events within 12 months prior to screening.

  5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.

  6. Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.

  7. Present or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other more serious mental illness.

  8. Surgery is planned during the trial.

  9. Mentally incapacitated or speech-impaired.

  10. Pregnant or lactating woman.

  11. In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujian Shengdi Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05966272
Other Study ID Numbers:
  • HRS9531-202
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 28, 2023