A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
2026년 5월 13일 업데이트: 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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
120
단계
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Novo Nordisk
- 전화번호: (+1) 866-867-7178
- 이메일: clinicaltrials@novonordisk.com
연구 장소
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Berlin, 독일, 14050
- 모병
- Parexel International GmbH
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
기간: 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)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
기간: From baseline (Day 2) to end of treatment (Day 127)
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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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 연구 책임자: Clinical Transparency' (dept. 2834), Novo Nordisk A/S
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NN9833-8421
- U1111-1325-8810 (기타 식별자: World Health Organization (WHO))
- 2025-524206-15 (기타 식별자: European Medical Agency (EMA))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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예
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