Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity

ConditionOverweight or Obesity
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of once-weekly HRS-4729 injection in adults with obesity without diabetes. Approximately 252 participants will be enrolled. The primary endpoint is percent change in body weight from baseline at Week 32 versus placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Able and willing to provide a written informed consent.

Male or female adults aged 18 to 65 years.

BMI: 28.0 to 40.0 kg/m2.

Self-reported diet and exercise control for at least 3 months before screening, with body weight change of no more than 5 kg during the previous 3 months.

Disqualifiers

Endocrine disease or history that may have a significant effect on body weight;

History of diabetes mellitus (gestational diabetes excepted);

Malignancy of any organ system within the past 5 years, irrespective of evidence of local recurrence or metastasis, except for adequately treated localized basal cell carcinoma of the skin, carcinoma in situ of the cervix, and prostate carcinoma in situ;

Presence or suspicion of depression, anxiety disorder, bipolar disorder, suicidal ideation, schizophrenia, or other clinically significant psychiatric disorder, or a history of suicide attempt;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-4729 Injection

    Drug

    HRS-4729 Injection; Dose 1

  • HRS-4729 Injection

    Drug

    HRS-4729 Injection; Dose 2

  • HRS-4729 Injection

    Drug

    HRS-4729 Injection; Dose 3

  • HRS-4729 Injection;

    Drug

    HRS-4729 Injection; Dose 4

  • HRS-4729 Injection;

    Drug

    HRS-4729 Injection; Dose 5

  • HRS-4729 Injection;

    Drug

    HRS-4729 Injection; Dose 6

  • HRS-4729 Injection Placebo

    Drug

    HRS-4729 Injection Placebo

Treatment groups

252 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose 1Experimental treatment 1 intervention
Group B: Dose 2Experimental treatment 1 intervention
Group C: Dose 3Experimental treatment 1 intervention
Group D: Dose 4Experimental treatment 1 intervention
Group E: Dose 5Experimental treatment 1 intervention
Group F: Dose 6Experimental treatment 1 intervention
Group G: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change From Baseline in Body Weight

Time frame
Baseline, Week 32

Secondary outcomes

1

Percent Change From Baseline in Body Weight

Time frame
Baseline, Week 40
2

Change From Baseline in Body Weight

Time frame
Baseline, Week 32 and 40
3

Change from Baseline in Body Mass Index (BMI)

Time frame
Baseline, Week 32 and 40
4

Change from Baseline in Waist Circumference

Time frame
Baseline, Week 32 and 40

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: