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Trial · Interventional

Not yet recruitingPhase 2Registry data

A Study of HRS-4729 Injection in Participants With Type 2 Diabetes

NCTNCT07843862 (opens ClinicalTrials.gov in a new tab)Other idHRS-4729-203
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 2
Enrollment
240 participants (estimated)
Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
Oct 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
First posted
28 Sept 2026
Last update posted
28 Sept 2026
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 2

    A Study of HRS-4729 Injection in Participants With Type 2 Diabetes

    NCT07843862

    est. Oct 2026 to est. Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin.

Interventions

  • HRS-4729 InjectionDrug
  • MazdutideDrug
  • PlaceboDrug

Arms6

  • Experimental

    Treatment group A

  • Experimental

    Treatment group B

  • Experimental

    Treatment group C

  • Experimental

    Treatment group D

  • Active comparator

    Mazdutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in HbA1c

    Time frame · Baseline, Week 28

Secondary outcomes(4)

  1. Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7%

    Time frame · Baseline, Week 28

  2. Percent Change From Baseline in Body Weight

    Time frame · Baseline, Week 28

  3. Change From Baseline in Fasting Plasma Glucose

    Time frame · Baseline, Week 28

  4. TEAEs

    Time frame · Baseline, Week 32

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Have Type 2 Diabetes 2. Treated with diet and exercise alone or with a stable dose of metformin 3. Have an HbA1c value at screening of ≥7.5% and ≤10.5% Exclusion Criteria: 1. Have uncontrolled hypertension 2. Have Type 1 Diabetes, or specific types of diabetes 3. History of acute diabetic complications or severe hypoglycemic events 4. History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment 5. History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery 6. History or known history of acute or chronic pancreatitis, or pancreatic injury 7. History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease 8. Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)

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