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

31 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

94

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: IBI3042 treatment Group
Geneesmiddel: IBI3042
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Experimenteel: Placebo Control Group
Geneesmiddel: Placebo
Matching oral placebo is administered as single or multiple doses according to the study protocol.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Number of Participants With Adverse Events (Part A)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Number of Participants With Adverse Events (Part B)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Area under the blood concentration-time curve (AUC) (Part A)
Tijdsspanne: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Peak Plasma Concentration (Cmax) (Part A)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Apparent Clearance (CL/F) (Part A)
Tijdsspanne: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Apparent Volume of Distribution (Vz/F) (Part A)
Tijdsspanne: Through study completion, an average of 29 days.
Through study completion, an average of 29 days.
Terminal Half-Life (T1/2) (Part A)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Peak Plasma Concentration (Cmax) (Part B)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Clearance (CL/F) (Part B)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Apparent Volume of Distribution (Vz/F) (Part B)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Terminal Half-Life (T1/2) (Part B)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in body weight from baseline (Part B)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.
Changes in waist circumference from baseline (Part B)
Tijdsspanne: Through study completion, an average of 57 days.
Through study completion, an average of 57 days.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hongwei Jiang

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

2 september 2026

Primaire voltooiing (Geschat)

20 maart 2027

Studie voltooiing (Geschat)

2 mei 2027

Studieregistratiedata

Eerst ingediend

31 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

31 augustus 2026

Eerst geplaatst (Werkelijk)

3 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

31 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CIBI3042T001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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