A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
13 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
120
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Novo Nordisk
- Numero di telefono: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Luoghi di studio
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Berlin, Germania, 14050
- Reclutamento
- Parexel International GmbH
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Cagrilintide
Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.
|
Cagrilintide is administered subcutaneously .
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Comparatore placebo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Lasso di tempo: From baseline (Day 2) to end of treatment (Day 127)
|
Measured in percentage (%).
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From baseline (Day 2) to end of treatment (Day 127)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Lasso di tempo: From baseline (Day 2) to end of treatment (Day 127)
|
Measured in kilojoule (kJ).
|
From baseline (Day 2) to end of treatment (Day 127)
|
|
Change in total amount of food consumed across ad libitum breakfast, lunch, evening meal and snack box
Lasso di tempo: From baseline (Day 2) to end of treatment (Day 127)
|
Measured in grams (g).
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From baseline (Day 2) to end of treatment (Day 127)
|
|
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
Lasso di tempo: From baseline (Day 2) to end of treatment (Day 127)
|
Measured in kJ.
|
From baseline (Day 2) to end of treatment (Day 127)
|
|
Change in mean postprandial appetite score (AS) based on Visual Analogue Scale (VAS)
Lasso di tempo: From baseline (Day 1) to end of treatment (Day 126)
|
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
Lasso di tempo: 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.
|
From baseline (Day 1) to end of treatment (Day 126)
|
|
Change in mean postprandial VAS ratings of: visual appearance, taste and overall pleasantness
Lasso di tempo: From baseline (Day 1) to end of treatment (Day 126)
|
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.
|
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
Lasso di tempo: 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.
|
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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Clinical Transparency' (dept. 2834), Novo Nordisk A/S
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
30 aprile 2026
Completamento primario (Stimato)
13 aprile 2027
Completamento dello studio (Stimato)
13 aprile 2027
Date di iscrizione allo studio
Primo inviato
23 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
23 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
15 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NN9833-8421
- U1111-1325-8810 (Altro identificatore: World Health Organization (WHO))
- 2025-524206-15 (Altro identificatore: European Medical Agency (EMA))
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .