An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants
2026年8月31日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
94
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Hongwei Jiang
- 電話番号：+86-0379-64830815
- メール：jianghw@haust.edu.cn
研究場所
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Hennan
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Luoyang、Hennan、中国
- The First Affiliated Hospital of Henan University of Science and Technology
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コンタクト：
- Caie Wang
- 電話番号：+86-0379-64830815
- メール：245454618@qq.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants With Adverse Events (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Abnormal Physical Examination Findings (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
時間枠：Through study completion, an average of 29 days.
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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)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Adverse Events (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Number of Participants With Abnormal Physical Examination Findings (Part B)
時間枠：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 Vital Signs (Part B)
時間枠：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)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
|
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Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Area under the blood concentration-time curve (AUC) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
|
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Peak Plasma Concentration (Cmax) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Time to Reach Peak Plasma Concentration (Tmax) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Apparent Clearance (CL/F) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Apparent Volume of Distribution (Vz/F) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Terminal Half-Life (T1/2) (Part A)
時間枠：Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
|
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Peak Plasma Concentration (Cmax) (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Time to Reach Peak Plasma Concentration (Tmax) (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Apparent Clearance (CL/F) (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Apparent Volume of Distribution (Vz/F) (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Terminal Half-Life (T1/2) (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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Changes in body weight from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Percentage change in body weight from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Percentage change in waist circumference from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Percentage change in body mass index (BMI) from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Body Mass Index (BMI) change from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
|
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Changes in waist circumference from baseline (Part B)
時間枠：Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月2日
一次修了 (推定)
2027年3月20日
研究の完了 (推定)
2027年5月2日
試験登録日
最初に提出
2026年8月31日
QC基準を満たした最初の提出物
2026年8月31日
最初の投稿 (実際)
2026年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月3日
QC基準を満たした最後の更新が送信されました
2026年8月31日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。