An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants
31 sierpnia 2026 zaktualizowane przez: Hongwei Jiang
An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.
The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.
Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
94
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Hongwei Jiang
- Numer telefonu: +86-0379-64830815
- E-mail: jianghw@haust.edu.cn
Lokalizacje studiów
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Hennan
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Luoyang, Hennan, Chiny
- The First Affiliated Hospital of Henan University of Science and Technology
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Kontakt:
- Caie Wang
- Numer telefonu: +86-0379-64830815
- E-mail: 245454618@qq.com
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Aged 18 to 55 years, inclusive.
- For Part A: BMI ≥20 and<28 kg/m^2 and body weight ≥50 kg.
- For Part B: BMI ≥24 and ≤40 kg/m^2, with stable body weight during the 3 months prior to screening.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Able and willing to comply with study procedures and voluntarily provide written informed consent.
Exclusion Criteria:
- Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- History of diabetes or abnormal glycemic parameters at screening.
- Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
- Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
- Clinically significant abnormalities in physical examination or laboratory tests at screening.
- History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
- Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.
- Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: IBI3042 treatment Group
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IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
|
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Eksperymentalny: Placebo Control Group
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Matching oral placebo is administered as single or multiple doses according to the study protocol.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Number of Participants With Adverse Events (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Number of Participants With Abnormal Physical Examination Findings (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
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Number of Participants With Adverse Events (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Number of Participants With Abnormal Physical Examination Findings (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Area under the blood concentration-time curve (AUC) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
|
Peak Plasma Concentration (Cmax) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Apparent Clearance (CL/F) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
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Apparent Volume of Distribution (Vz/F) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
|
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Terminal Half-Life (T1/2) (Part A)
Ramy czasowe: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
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Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Peak Plasma Concentration (Cmax) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Apparent Clearance (CL/F) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Apparent Volume of Distribution (Vz/F) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Terminal Half-Life (T1/2) (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Changes in body weight from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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Percentage change in body weight from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Percentage change in waist circumference from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Percentage change in body mass index (BMI) from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Body Mass Index (BMI) change from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
|
Changes in waist circumference from baseline (Part B)
Ramy czasowe: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
2 września 2026
Zakończenie podstawowe (Szacowany)
20 marca 2027
Ukończenie studiów (Szacowany)
2 maja 2027
Daty rejestracji na studia
Pierwszy przesłany
31 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
31 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
3 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
3 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
31 sierpnia 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CIBI3042T001
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIEZDECYDOWANY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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