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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity

ConditionOverweight and Obesity
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;

At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";

Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);

Disqualifiers

Presence of clinically significant lab results at screening visit;

Uncontrollable hypertension;

Medical history or illness that affects your weight;

History of diabetes;

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS9531 injection；Placebo

    Drug

    Drug: HRS9531 injection; low dose Drug: Placebo

  • HRS9531 injection；Placebo

    Drug

    Drug: HRS9531 injection; medium dose Drug: Placebo

  • HRS9531 injection；Placebo

    Drug

    Drug: HRS9531 injection; high dose Drug: Placebo

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Treatment group A: HRS9531 injection or PlaceboExperimental treatment 1 intervention
Group B: Treatment group B: HRS9531 injection or PlaceboExperimental treatment 1 intervention
Group C: Treatment group C: HRS9531 injection or PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Time frame
up to Week 28

Secondary outcomes

1

Maximum concentration (Cmax) of HRS9531

Time frame
up to Week 28
2

Trough concentration (Ctrough) of HRS9531

Time frame
up to Week 28
3

Area under the curve from time zero to end of dosing interval (AUC0-tau)

Time frame
up to Week 28
4

Changes from baseline in BMI

Time frame
up to Week 24

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: