A Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Obesity
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HRS-4729 Injection in Participants With Obesity
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Ziwei Du
- Telefonnummer: +86 0518-81220121
- E-mail: ziwei.du.zd9@hengrui.com
Studiesteder
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200025
- Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
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Ledende efterforsker:
- Weiqing Wang
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Known or suspected excessive alcohol use, or a history of alcohol, drug, or substance abuse;
- Acute or chronic hepatitis, or a history of severe hepatic disease other than metabolic dysfunction-associated fatty liver disease;
- Prior or planned organ or bone marrow transplantation during the study period;
- Any hematologic disorder that may interfere with the determination of HbA1c;
- An autoimmune disease for which systemic corticosteroid or immunosuppressive therapy is planned during the study period;
- Use of any medication or treatment likely to cause clinically significant weight gain or weight loss within 3 months prior to screening;
- Participation in any clinical trial of an investigational drug or medical device within 3 months prior to screening;
- Blood donation or blood loss ≥400 mL, or receipt of a blood transfusion, within 3 months prior to screening;
- Mental incapacity or language impairment sufficient to preclude adequate understanding of, or participation in, the trial procedures;
- Investigators, site staff, or other personnel directly involved in conduct of the study, and their immediate family members; employees of the Sponsor;
- Any condition that, in the investigator's judgment, would compromise participant safety or otherwise interfere with the assessment of study results.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Dose 1
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 1
HRS-4729 Injection; Dose 2
HRS-4729 Injection; Dose 3
|
|
Eksperimentel: Dose 2
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 1
HRS-4729 Injection; Dose 2
HRS-4729 Injection; Dose 3
|
|
Eksperimentel: Dose 3
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 1
HRS-4729 Injection; Dose 2
HRS-4729 Injection; Dose 3
|
|
Eksperimentel: Dose 4
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 4
HRS-4729 Injection; Dose 5
HRS-4729 Injection; Dose 6
|
|
Eksperimentel: Dose 5
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 4
HRS-4729 Injection; Dose 5
HRS-4729 Injection; Dose 6
|
|
Eksperimentel: Dose 6
Drug: HRS-4729 Injection
|
HRS-4729 Injection; Dose 4
HRS-4729 Injection; Dose 5
HRS-4729 Injection; Dose 6
|
|
Placebo komparator: Placebo
Drug: HRS-4729 Injection Placebo
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HRS-4729 Injection Placebo
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change From Baseline in Body Weight
Tidsramme: Baseline, Week 32
|
Baseline, Week 32
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent Change From Baseline in Body Weight
Tidsramme: Baseline, Week 40
|
Baseline, Week 40
|
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Change From Baseline in Body Weight
Tidsramme: Baseline, Week 32 and 40
|
Baseline, Week 32 and 40
|
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Change from Baseline in Body Mass Index (BMI)
Tidsramme: Baseline, Week 32 and 40
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Baseline, Week 32 and 40
|
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Change from Baseline in Waist Circumference
Tidsramme: Baseline, Week 32 and 40
|
Baseline, Week 32 and 40
|
|
Change from Baseline in Blood Pressure
Tidsramme: Baseline, Week 32 and 40
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Baseline, Week 32 and 40
|
|
Change from Baseline in Glucose Level
Tidsramme: Baseline, Week 32 and 40
|
Baseline, Week 32 and 40
|
|
TEAEs
Tidsramme: Baseline, Week 44
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Baseline, Week 44
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS-4729-202
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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