Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

31 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

94

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: IBI3042 treatment Group
Läkemedel: IBI3042
IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
Experimentell: Placebo Control Group
Läkemedel: Placebo
Matching oral placebo is administered as single or multiple doses according to the study protocol.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Hongwei Jiang

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

2 september 2026

Primärt slutförande (Beräknad)

20 mars 2027

Avslutad studie (Beräknad)

2 maj 2027

Studieregistreringsdatum

Först inskickad

31 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

31 augusti 2026

Första postat (Faktisk)

3 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CIBI3042T001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera