- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07559136
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with obesity
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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);
Exclusion Criteria:
- Presence of clinically significant lab results at screening visit;
- Uncontrollable hypertension;
- Medical history or illness that affects your weight;
- History of diabetes;
- Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
- Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- Pre-adolescent participants (Tanner phase I);
- Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
- Surgery is planned during the tria;
- Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;
- In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Treatment group A: HRS9531 injection or Placebo
|
Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
|
Experimentell: Treatment group B: HRS9531 injection or Placebo
|
Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
|
Experimentell: Treatment group C: HRS9531 injection or Placebo
|
Drug: HRS9531 injection; low dose Drug: Placebo Drug: HRS9531 injection; medium dose Drug: Placebo Drug: HRS9531 injection; high dose Drug: Placebo |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Adverse Events (AEs)
Tidsram: up to Week 28
|
up to Week 28
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Maximum concentration (Cmax) of HRS9531
Tidsram: up to Week 28
|
up to Week 28
|
|
Trough concentration (Ctrough) of HRS9531
Tidsram: up to Week 28
|
up to Week 28
|
|
Area under the curve from time zero to end of dosing interval (AUC0-tau)
Tidsram: up to Week 28
|
up to Week 28
|
|
Changes from baseline in BMI
Tidsram: up to Week 24
|
up to Week 24
|
|
Change from baseline in body weight
Tidsram: up to Week 24
|
up to Week 24
|
|
Change from baseline in waist circumference
Tidsram: up to Week 24
|
up to Week 24
|
|
Anti-HRS9531 antibodies (ADA)
Tidsram: up to Week 28
|
up to Week 28
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HRS9531-111
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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