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An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants

31. August 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

94

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Hennan
      • Luoyang, Hennan, China
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: IBI3042 treatment Group
Arzneimittel: IBI3042
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Experimental: Placebo Control Group
Arzneimittel: Placebo
Matching oral placebo is administered as single or multiple doses according to the study protocol.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Number of Participants With Adverse Events (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Abnormal Physical Examination Findings (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Abnormal Physical Examination Findings (Part B)
Zeitfenster: 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)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Zeitfenster: 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)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Area under the blood concentration-time curve (AUC) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Apparent Clearance (CL/F) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Apparent Volume of Distribution (Vz/F) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Terminal Half-Life (T1/2) (Part A)
Zeitfenster: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Peak Plasma Concentration (Cmax) (Part B)
Zeitfenster: 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)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Clearance (CL/F) (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Volume of Distribution (Vz/F) (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Terminal Half-Life (T1/2) (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in body weight from baseline (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Percentage change in body weight from baseline (Part B)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in waist circumference from baseline (Part B)
Zeitfenster: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hongwei Jiang

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

2. September 2026

Primärer Abschluss (Geschätzt)

20. März 2027

Studienabschluss (Geschätzt)

2. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

31. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2026

Zuerst gepostet (Tatsächlich)

3. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CIBI3042T001

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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