- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07599410
A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus
21. juli 2026 opdateret af: Fujian Shengdi Pharmaceutical Co., Ltd.
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.
The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin.
This study will last 20 weeks.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
240
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
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
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
Resultatmål |
Tidsramme |
|---|---|
|
Change in glycated hemoglobin (HbA1c) relative to baseline
Tidsramme: Week 20.
|
Week 20.
|
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
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. juli 2026
Primær færdiggørelse (Anslået)
1. maj 2027
Studieafslutning (Anslået)
1. juli 2027
Datoer for studieregistrering
Først indsendt
11. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. maj 2026
Først opslået (Faktiske)
20. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HRS9531-T-202
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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