Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

31. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

94

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Hennan
      • Luoyang, Hennan, Kina
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Ta kontakt med:

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

Tar imot friske frivillige

Ja

Beskrivelse

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.

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: Sekvensiell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: IBI3042 treatment Group
Legemiddel: IBI3042
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Eksperimentell: Placebo Control Group
Legemiddel: Placebo
Matching oral placebo is administered as single or multiple doses according to the study protocol.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Hongwei Jiang

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 (Antatt)

2. september 2026

Primær fullføring (Antatt)

20. mars 2027

Studiet fullført (Antatt)

2. mai 2027

Datoer for studieregistrering

Først innsendt

31. august 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CIBI3042T001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere