Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses
A Phase 1, Open-label, Randomized, Parallel Group, Multiple Dose Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity
The main objective of this study is to compare the pharmacokinetics of maridebart cafraglutide administered as a single dose using two different subcutaneous (SC) presentations in participants with overweight or obesity after they have received escalating doses of the study drug.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Amgen Call Center
- 電話番号:866-572-6436
- メール:medinfo@amgen.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults 18 to 60 years of age.
- Body mass index (BMI) between 25 and 35 kilograms per square meter (kg/m^2), inclusive.
- Stable body weight, with less than 5 kilograms (kg) (11 pounds) of weight change in the past 3 months.
- No significant changes in diet or eating habits in the past 3 months.
- Generally healthy. People with certain well-controlled medical conditions, such as sleep apnea, high blood pressure, high cholesterol, or underactive thyroid, may qualify if their treatment has been stable for at least 3 months and is approved by the study doctor.
- Willing to follow the study's birth control requirements, if applicable, during the study and for the study-defined period after the last dose of study drug.
- Able and willing to provide informed consent before participating in study procedures.
Exclusion Criteria:
- History of diabetes or current diabetes, except diabetes during pregnancy, or blood sugar levels that meet the study's definition of diabetes.
- Certain hormonal conditions that can cause weight gain, such as Cushing's syndrome.
- History of pancreatitis (inflammation of the pancreas) or certain abnormal pancreatic blood test results.
- History of cancer within the past 5 years, except certain early-stage cancers or nonmelanoma skin cancers.
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
- Uncontrolled thyroid disease or certain abnormal thyroid blood test results.
- Significant stomach or intestinal conditions, including delayed stomach emptying, ulcers, or inflammatory bowel disease, or a history of certain digestive system surgeries.
- Weight-loss surgery within the past 6 months.
- Significant heart disease, abnormal heart rhythms, or blood pressure or heart rate outside the study's allowed limits.
- Significant kidney or liver problems, or certain abnormal kidney or liver blood test results.
- Positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, with certain exceptions for past hepatitis B vaccination or infection.
- History of certain serious or unstable mental health conditions, self-injury within the past 5 years, or any previous suicide attempt.
- History of ischemic optic neuropathy, a condition involving damage to the optic nerve caused by reduced blood flow.
- Allergy or intolerance to maridebart cafraglutide (AMG 133), similar medications, or their ingredients.
- Use of certain medications, including weight-loss or diabetes medications that act on glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP), within the restricted time periods before the study.
- Use of certain herbal products, vitamins, or supplements within 30 days before enrollment, unless approved by the study doctor.
- Recent participation in another investigational drug study or previous participation in a study of maridebart cafraglutide.
- History of alcohol or drug abuse, recent illegal drug use, or positive alcohol or drug screening results not explained by permitted prescription medications.
- Pregnant, breastfeeding, or planning to breastfeed during the study or within the study-defined period after the last dose of study drug.
- Recent blood, plasma, or platelet donation within the study's restricted time periods.
- Recent strenuous exercise or unwillingness to follow study restrictions on physical activity, alcohol, recreational drugs, diet, or other activities.
- Difficulty providing blood samples because of poor vein access.
- Any other medical condition, abnormal test result, or circumstance that the study doctor believes could make participation unsafe or interfere with study procedures.
研究計画
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:基礎科学
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Maridebart Cafraglutide: SC Presentation 1
Participants will receive maridebart cafraglutide administered subcutaneously (SC) during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 1. |
Administered subcutaneously.
他の名前:
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実験的:Maridebart Cafraglutide: SC Presentation 2
Participants will receive maridebart cafraglutide administered SC during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 2. |
Administered subcutaneously.
他の名前:
|
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 |
|---|---|
|
Area Under the Plasma Concentration-time Curve from Time 0 to 28 days post dose (AUC 0-28) of Maridebart Cafraglutide
時間枠:Up to 113 days
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Up to 113 days
|
|
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
時間枠:Up to 113 days
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Up to 113 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠:TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
|
TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
|
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Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
時間枠:Baseline (Day 1) up to end of trial (approximately 28 weeks)
|
Baseline (Day 1) up to end of trial (approximately 28 weeks)
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:MD、Amgen
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20260175
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD 共有アクセス基準
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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