A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
A Study Investigating the Effect of Cagrilintide on Energy Intake and Appetite in People With Overweight or Obesity
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 1
Contatti e Sedi
Contatto 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
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
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
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: 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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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
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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)
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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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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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)
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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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: From baseline (Day 1) to end of treatment (Day 126)
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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
Lasso di tempo: 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
Lasso di tempo: From baseline (Day 1) to end of treatment (Day 126)
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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
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
Sponsor
Sponsor
Investigatori
Investigatori
- Direttore dello studio: Clinical Transparency' (dept. 2834), Novo Nordisk A/S
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
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))
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