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

NCT07843862 | Not Yet Recruiting Phase 2

• 1 other identifier: HRS-4729-203
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c

  Baseline, Week 28

Secondary Outcomes (4)

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

  Baseline, Week 28

• Percent Change From Baseline in Body Weight

  Baseline, Week 28

• Change From Baseline in Fasting Plasma Glucose

  Baseline, Week 28

• TEAEs

  Baseline, Week 32

Study Arms (6)

Treatment group A

EXPERIMENTAL

Drug: HRS-4729 Injection

Treatment group B

EXPERIMENTAL

Drug: HRS-4729 Injection

Treatment group C

EXPERIMENTAL

Drug: HRS-4729 Injection

Treatment group D

EXPERIMENTAL

Drug: HRS-4729 Injection

Mazdutide

ACTIVE COMPARATOR

Drug: Mazdutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS-4729 Injection DRUG

HRS-4729 Injection

Treatment group A; Treatment group B; Treatment group C; Treatment group D

Mazdutide DRUG

Mazdutide

Mazdutide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have Type 2 Diabetes
• Treated with diet and exercise alone or with a stable dose of metformin
• Have an HbA1c value at screening of ≥7.5% and ≤10.5%

You may not qualify if:

• Have uncontrolled hypertension
• Have Type 1 Diabetes, or specific types of diabetes
• History of acute diabetic complications or severe hypoglycemic events
• History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment
• History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery
• History or known history of acute or chronic pancreatitis, or pancreatic injury
• History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease
• Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

Wuhan, Hubei, 430030, China

Location

Tianjin Medical University Chu Hsien-I Memorial Hospital

Tianjin, Tianjin Municipality, 300134, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

mazdutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mengshan Ni, M.D.

CONTACT

+86 0518-81220121; mengshan.ni.mn1@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Phase II, Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Clinical Study

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

CN (2)