- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07599410
A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus
21. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
240
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Junmeng Shi
- Telefonnummer: 17721288226
- E-post: junmeng.shi.js12@hengrui.com
Studiesteder
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100020
- Rekruttering
- Beijing Chaoyang Hospital, Capital Medical University
-
Hovedetterforsker:
- Guang Wang
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Rekruttering
- Qilu Hospital of Shandong University
-
Hovedetterforsker:
- Xinguo Hou
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Behandlingsgruppe A: HRS9531 tablett
|
HRS9531 tablettdose 1
HRS9531 tablettdose 2
HRS9531 tablettdose 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentell: Behandlingsgruppe B: HRS9531 tablett
|
HRS9531 tablettdose 1
HRS9531 tablettdose 2
HRS9531 tablettdose 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentell: Behandlingsgruppe C: HRS9531 tablett
|
HRS9531 tablettdose 1
HRS9531 tablettdose 2
HRS9531 tablettdose 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentell: Treatment group D: HRS9531 Tablet
|
HRS9531 tablettdose 1
HRS9531 tablettdose 2
HRS9531 tablettdose 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Eksperimentell: Treatment group E: HRS9531 Tablet
|
HRS9531 tablettdose 1
HRS9531 tablettdose 2
HRS9531 tablettdose 3
HRS9531 Tablet dose 4
HRS9531 Tablet dose 5
|
|
Placebo komparator: Treatment group F:Placebo
|
HRS9531 Tablet placebo
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. juli 2026
Primær fullføring (Antatt)
1. mai 2027
Studiet fullført (Antatt)
1. juli 2027
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
14. mai 2026
Først lagt ut (Faktiske)
20. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HRS9531-T-202
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
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Nei
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