- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07929298
A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Efficacy of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
The aim of the study is to evaluate the safety and efficacy of oral ecnoglutide tablets in Chinese participants with overweight or obesity
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Yao Li
- Telefonnummer: 010-67889253
- E-mail: ra@sciwindbio.com
Studiesteder
-
-
Henan
-
Luoyang, Henan, Kina
- The First Affiliated Hospital of Henan University of Science & Technology
-
Kontakt:
- Hongwei Jiang
- Telefonnummer: 010-67889253
- E-mail: ra@sciwindbio.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- At the time of informed consent, BMI≥28.0 kg/m^2 regardless of comorbidities, or 24.0kg/m^2≤BMI<28.0 kg/m^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
- Self-declaration of body weight change <5% within 3 months prior to informed consent;
Exclusion Criteria:
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows C-TIRADS≥ class 4A), Medullary thyroid carcinoma, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
- Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: oral ecnoglutide dose 1
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Eksperimentel: oral ecnoglutide dose 2
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Eksperimentel: oral ecnoglutide dose 3
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
|
Placebo komparator: Placebo
once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24 |
oral tablet |
|
Eksperimentel: oral ecnoglutide dose 4
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage Change in Body Weight
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with ≥5% of Body Weight Loss
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥10% of Body Weight Loss
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥15% of Body Weight Loss
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Absolute Change in Body Weight
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in Body Mass Index (BMI)
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood pressure
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in other body measurements
Tidsramme: Baseline, week 24
|
Body measurements include neck circumference, waist circumference, hip circumference |
Baseline, week 24
|
|
Change in lipid profile
Tidsramme: Baseline, week 24
|
Include triglicerides, LDL-C, HDL-C, total cholesterol |
Baseline, week 24
|
|
Change in fasting blood glucose (FBG)
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in HbA1c
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in fasting insulin
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood uric acid
Tidsramme: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in liver enzymes
Tidsramme: Baseline, week 24
|
include ALT and AST |
Baseline, week 24
|
|
Adverse events
Tidsramme: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
|
|
Plasma Concentration of Ecnoglutide
Tidsramme: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Hongwei Jiang, The First Affiliated Hospital of Henan University of Science and Technology
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCW0503-1121
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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