Health TrialsbyHealthPanel

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

ConditionType 2 Diabetes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4729 Injection

    Drug

    HRS-4729 Injection

  • Mazdutide

    Drug

    Mazdutide

  • Placebo

    Drug

    Placebo

Treatment groups

240 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BExperimental treatment 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention
Group D: Treatment group DExperimental treatment 1 intervention
Group E: MazdutideActive comparator 1 intervention
Group F: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: