A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
2026年5月13日 更新者：Novo Nordisk A/S
A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity.
Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance.
Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine.
The study will last for about 30 weeks.
調査の概要
研究の種類
介入
入学 (推定)
120
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：Novo Nordisk
- 電話番号：(+1) 866-867-7178
- メール：clinicaltrials@novonordisk.com
研究場所
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Berlin、ドイツ、14050
- 募集
- Parexel International GmbH
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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
いいえ
説明
Inclusion Criteria:
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion Criteria:
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
- History of type 1 or type 2 diabetes mellitus
- Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
- Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
- Previous dosing of marketed or non-marketed amylin-based compounds.
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：並列代入
- マスキング：4倍
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：Cagrilintide
Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.
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Cagrilintide is administered subcutaneously .
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プラセボコンパレーター：Placebo Cagrilintide
Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks.
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Placebo Cagrilintide is administered subcutaneously.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
時間枠：From baseline (Day 2) to end of treatment (Day 127)
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Measured in percentage (%).
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From baseline (Day 2) to end of treatment (Day 127)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
時間枠：From baseline (Day 2) to end of treatment (Day 127)
|
Measured in kilojoule (kJ).
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From baseline (Day 2) to end of treatment (Day 127)
|
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Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box
時間枠：From baseline (Day 2) to end of treatment (Day 127)
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Measured in grams (g).
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From baseline (Day 2) to end of treatment (Day 127)
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Absolute change in energy intake of high fat + sweet, high fat + non-sweet, low fat + sweet, low fat + non sweet in the evening snack box
時間枠：From baseline (Day 2) to end of treatment (Day 127)
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Measured in kJ.
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From baseline (Day 2) to end of treatment (Day 127)
|
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Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)
時間枠：From baseline (Day 1) to end of treatment (Day 126)
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Measured in millimetre(mm).
VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm.
The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4.
Scores of 0 mm are worst and scores of 100 mm are best.
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From baseline (Day 1) to end of treatment (Day 126)
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Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption
時間枠：From baseline (Day 1) to end of treatment (Day 126)
|
Measured in mm.
VAS appetite questions record the participants' sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm.
The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4.
Scores of 0 mm are worst and scores of 100 mm are best.
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From baseline (Day 1) to end of treatment (Day 126)
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Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness
時間枠：From baseline (Day 1) to end of treatment (Day 126)
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Measured in mm.
VAS appeal questions record the participant's sensations within taste, visual appearance and overall pleasantness by the participants on a paper printed scale line from 0 to 100 mm.
Scores of 0 mm are worst and scores of 100 mm are best.
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From baseline (Day 1) to end of treatment (Day 126)
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Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS
時間枠：From baseline (Day 1) to end of treatment (Day 126)
|
Measured in mm.
VAS appetite questions record the participant's sensations within Hunger, Satiety, Fullness and Prospective food consumption by the participants on a paper printed scale line from 0 to 100 mm.
The appetite score will be calculated as [hunger + (100 - satiety) + (100 - fullness) + prospective food consumption]/4.
Scores of 0 mm are worst and scores of 100 mm are best.
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From baseline (Day 1) to end of treatment (Day 126)
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• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score
時間枠：From baseline (Day -1) to end of treatment (Day 125)
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Measured in score points.
The COEQ is a self-reported measure assessing various aspects of eating behaviour and related psychological factors.
The COEQ has 19 different questions designed to assess the intensity and type of food cravings, as well as subjective sensations of appetite and mood.
The total score for each subscale is calculated as the sum of the item scores divided by the number of items in the subscale.
Scores ranges are thus: Craving Control (0-50/5 = 0-10); Positive Mood (0-40/4 = 0-10); Craving Sweet (0-40/4 = 0-10); Craving Savoury food (0-40/4 = 0-10); Higher score represents a greater level of Craving Control.
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From baseline (Day -1) to end of treatment (Day 125)
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Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score
時間枠：From baseline (Day -1) to end of treatment (Day 125)
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Measured in score points.
The power of food questionnaire measures three factors that correspond to different levels of food proximity and reflect responsiveness to food-abundant environments: food available (food that is available, but not physically present), food present (food that is present, but not tasted), and food tasted (food that is tasted, but not consumed).
Moreover, an aggregate score is calculated as the mean of the three subdomains.
The questionnaire consists of 15 questions, and the participants will be asked to rate their agreement or disagreement with each statement on a 5-point scale (ranging from "strongly disagree" to "strongly agree").
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From baseline (Day -1) to end of treatment (Day 125)
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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
捜査官
- スタディディレクター：Clinical Transparency' (dept. 2834)、Novo Nordisk A/S
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 (実際)
2026年4月30日
一次修了 (推定)
2027年4月13日
研究の完了 (推定)
2027年4月13日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月15日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NN9833-8421
- U1111-1325-8810 (その他の識別子：World Health Organization (WHO))
- 2025-524206-15 (その他の識別子：European Medical Agency (EMA))
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?
はい
IPD プランの説明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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
はい
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
はい
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