CClinicalTrials.gg
Sign In
Not yet recruitingNCT07843862Updated Sep 28, 2026

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

A Phase 2 interventional study of HRS-4729 Injection and Mazdutide in Type 2 Diabetes, sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Sep 28, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 240 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd. is the lead sponsor of 65 studies on the registry; 25 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Treatment group A

    Drug: HRS-4729 Injection

  • Experimental
    Treatment group B

    Drug: HRS-4729 Injection

  • Experimental
    Treatment group C

    Drug: HRS-4729 Injection

  • Experimental
    Treatment group D

    Drug: HRS-4729 Injection

  • Active comparator
    Mazdutide

    Drug: Mazdutide

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugHRS-4729 Injection

    HRS-4729 Injection

  • DrugMazdutide

    Mazdutide

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Change From Baseline in HbA1c

    Time frame: Baseline, Week 28

Secondary outcomes

  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

07

Study locations

2 sites
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
    Wuhan, Hubei 430030, China
    • Yan Yang · Principal investigator
  • Tianjin Medical University Chu Hsien-I Memorial Hospital
    Tianjin, Tianjin Municipality 300134, China
    • Liming Chen · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07843862
Lead sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Mengshan Ni, M.D.
Contact
mengshan.ni.mn1@hengrui.com
+86 0518-81220121

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Start the discussion