A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus
A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Junmeng Shi
- Telefonnummer: 17721288226
- E-mail: junmeng.shi.js12@hengrui.com
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100020
- Rekruttering
- Beijing Chaoyang Hospital, Capital Medical University
-
Ledende efterforsker:
- Guang Wang
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
-
Ledende efterforsker:
- Xinguo Hou
-
-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Male or female, aged 18 to 70 years on the day of signing the informed consent form;
- Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);
- HbA1c between 7.5% and 10.5% at screening;
- Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;
- Fasting plasma glucose ≤ 15 mmol/L;
- Body mass index (BMI) between 20.0 kg/m² and 40.0 kg/m² at screening;
- Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures and potential adverse reactions, and be able and willing to comply with protocol requirements to complete the study;
- Have no fertility plans from the signing of the informed consent form until 2 months after the last dose, and agree to use highly effective contraceptive measures as specified in the protocol.methods.
Exclusion Criteria:
- Participants with relevant abnormal test results at screening.
- Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.
- Participants with poorly controlled blood pressure.
- Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.
- Participants who experienced acute diabetic complications within 6 months prior to screening.
- Participants who experienced severe hypoglycemic events or recurrent hypoglycemic events within 6 months prior to screening.
- Participants with severe chronic diabetic complications at screening, or non-proliferative diabetic retinopathy requiring treatment during the trial.
- Participants with a past or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Participants with a past or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic/treatment requiring gallbladder disease.
- Participants with a past history of significant gastrointestinal diseases (such as severe diabetic gastroparesis, gastric outlet obstruction, inflammatory bowel disease, active ulcer, etc.), or who have undergone gastrointestinal surgery (excluding gastrointestinal polypectomy and appendectomy), or who are taking long-term medications that directly affect gastrointestinal motility.
- Participants with a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening.
- Participants with known or suspected depression, bipolar disorder, suicidal ideation, schizophrenia, or other severe psychiatric disorders; or participants who are mentally incompetent, have language barriers, are unable to fully understand the trial protocol, or are unwilling to cooperate with study site staff.
- Participants with a history of malignant tumor within 5 years prior to screening, except for cured localized cancers such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Any other conditions that, in the investigator's judgment, render the subject unsuitable for participation in this clinical trial.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Behandlingsgruppe A: HRS9531 Tablet
|
HRS9531 Tabletdosis 1
HRS9531 Tablet dosis 2
HRS9531 Tablet dosis 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentel: Behandlingsgruppe B: HRS9531 Tablet
|
HRS9531 Tabletdosis 1
HRS9531 Tablet dosis 2
HRS9531 Tablet dosis 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentel: Behandlingsgruppe C: HRS9531 Tablet
|
HRS9531 Tabletdosis 1
HRS9531 Tablet dosis 2
HRS9531 Tablet dosis 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentel: Treatment group D: HRS9531 Tablet
|
HRS9531 Tabletdosis 1
HRS9531 Tablet dosis 2
HRS9531 Tablet dosis 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentel: Treatment group E: HRS9531 Tablet
|
HRS9531 Tabletdosis 1
HRS9531 Tablet dosis 2
HRS9531 Tablet dosis 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Placebo komparator: Treatment group F:Placebo
|
HRS9531 Tablet Placebo
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in glycated hemoglobin (HbA1c) relative to baseline
Tidsramme: Week 20.
|
Week 20.
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of participants achieving HbA1c < 7.0%
Tidsramme: Week 20
|
Week 20
|
|
Percentage change in fasting body weight relative to baseline
Tidsramme: Week 20
|
Week 20
|
|
Change in fasting plasma glucose (FPG) relative to baseline
Tidsramme: Week 20
|
Week 20
|
|
Incidence of hypoglycemic events across all groups
Tidsramme: Week 20
|
Week 20
|
|
Incidence of adverse events (AEs) across all groups
Tidsramme: Week 20
|
Week 20
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- HRS9531-T-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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .