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A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity

13 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

120

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

      • Berlin, Duitsland, 14050
        • Werving
        • Parexel International GmbH

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cagrilintide
Participant will receive Cagrilintide subcutaneously once weekly for up to 17 weeks.
Cagrilintide is administered subcutaneously .
Placebo-vergelijker: Placebo Cagrilintide
Participant will receive placebo matched to Cagrilintide subcutaneously once weekly for up to 17 weeks.
Placebo Cagrilintide is administered subcutaneously.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Relative change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Tijdsspanne: From baseline (Day 2) to end of treatment (Day 127)
Measured in percentage (%).
From baseline (Day 2) to end of treatment (Day 127)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in total energy intake across ad libitum breakfast, lunch, evening meal and snack box
Tijdsspanne: 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
Tijdsspanne: From baseline (Day 2) to end of treatment (Day 127)
Measured in grams (g).
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
Tijdsspanne: 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)
Tijdsspanne: 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.
From baseline (Day 1) to end of treatment (Day 126)
Change in mean postprandial VAS ratings of: hunger, fullness, satiety and prospective food consumption
Tijdsspanne: 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
Tijdsspanne: 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)
Change in fasting VAS appetite ratings of: Hunger, fullness, satiety, prospective food consumption and AS
Tijdsspanne: 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)
• Change in mean Control of Eating questionnaire (CoEQ), domain: Craving Control score, positive mood score, craving for sweets score, craving for Savory food score
Tijdsspanne: From baseline (Day -1) to end of treatment (Day 125)
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.
From baseline (Day -1) to end of treatment (Day 125)
Change in mean Power of Food questionnaire for: food available score, food present score, food tasted score, composite score
Tijdsspanne: From baseline (Day -1) to end of treatment (Day 125)
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").
From baseline (Day -1) to end of treatment (Day 125)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Clinical Transparency' (dept. 2834), Novo Nordisk A/S

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 april 2026

Primaire voltooiing (Geschat)

13 april 2027

Studie voltooiing (Geschat)

13 april 2027

Studieregistratiedata

Eerst ingediend

23 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2026

Eerst geplaatst (Werkelijk)

30 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

13 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • NN9833-8421
  • U1111-1325-8810 (Andere identificatie: World Health Organization (WHO))
  • 2025-524206-15 (Andere identificatie: European Medical Agency (EMA))

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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