CClinicalTrials.gg
Status unknownNCT05759897Updated Mar 8, 2023

A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

A Phase 2 interventional study of HRS-7535 and Placebo in Type 2 Diabetes, sponsored by Shandong Suncadia Medicine Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-08.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 2, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's planned enrollment of 180 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female, 18-75 age years, both inclusive;
  2. Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
  3. HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
  4. Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
  5. Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);

Exclusion criteria

Exclusion Criteria:

  1. Known or suspected allergy to the investigational drug or its components or excipients.
  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.) within 6 months prior to screening.
  4. Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
  5. 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.
  6. Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.
  7. Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy).
  8. Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Group A

    Subjects will receive HRS-7535 administered orally

    Drug: HRS-7535

  • Experimental
    Group B

    Subjects will receive HRS-7535 administered orally

    Drug: HRS-7535

  • Experimental
    Group C

    Subjects will receive escalated dose of HRS-7535 administered orally

    Drug: HRS-7535

  • Experimental
    Group D

    Subjects will receive escalated HRS-7535 administered orally

    Drug: HRS-7535

  • Placebo comparator
    Group E

    Subjects will receive Placebo administered orally

    Drug: Placebo

Interventions

  • DrugHRS-7535

    HRS-7535

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Mean Change From Baseline in HbA1c at Week 16

    Time frame: at Week 16]

Secondary outcomes

  1. Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16

    Time frame: at Week 16

  2. Change From Baseline in fasting plasma glucose (FPG) at Week 16

    Time frame: at Week 16

  3. Change From Baseline in Mixed meal test at Week 16

    Time frame: at Week 16

  4. Change From Baseline in body weight at Week 16

    Time frame: at Week 16

  5. Change From Baseline in waist circumference at Week 16

    Time frame: at Week 16

  6. Change From Baseline in 7-point SMBG at Week 16

    Time frame: at Week 16

  7. Proportion of subjects receiving glycemic rescue medicine at Week 16

    Time frame: at Week 16

  8. A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[

    Time frame: at Week 18

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05759897
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Mar 8, 2023
Start date
Feb 28, 2023 (estimated)
Primary completion
Dec 21, 2023 (estimated)
Completion
Jan 4, 2024 (estimated)
Last update
Mar 8, 2023

Study contacts

Yimei Xu
Contact
yimei.xu@hengrui.com
0518-82342973
Shujin Cheng
Contact
shujin.cheng@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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