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Semaglutid-behandling, appetit og spiseadfærd: Langsigtede virkninger (STABLE Wt Loss)

30. juli 2026 opdateret af: University of Pennsylvania

Kort- og langsigtede virkninger af Semaglutid 2,4 mg én gang om ugen på appetit, spiseadfærd og psykosocial status

Denne undersøgelse vil evaluere effekten af ​​semaglutid på spiseadfærd, appetit (sult/mæthed) og madlyst på lang sigt sammenlignet med placebo. Alle deltagere vil modtage rådgivning om livsstilsændringer (kost og motion) og vil blive ordineret den FDA-godkendte vægttabsmedicin, semaglutid eller placebo (en inaktiv saltvandsopløsning) i 72 uger.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette forsøg består af en enkelt 72-ugers behandlingsperiode, hvor to undersøgelser vil blive udført. Undersøgelse 1 (dvs. langtidsbehandlingsforsøg; uge 0-60) er et 60-ugers, enkeltcenter, dobbeltblindet, randomiseret kontrolleret, parallelgruppedesignforsøg, og undersøgelse 2 (dvs. re-randomiseret medicintilbagetrækningsforsøg; uge 60-72) er et separat, 12-ugers, dobbeltblindt, re-randomiseret medicinabstinensforsøg.

Langtidsbehandlingsstudiet (Studie 1) vil tilfældigt tildele (i et 3:2 semaglutid:placebo-forhold) 120 forsøgspersoner med et kropsmasseindeks (BMI) ≥30 kg/m2 eller ≥27 kg/m2 med ≥1 fedme -relaterede komorbiditeter, til 60 uger af: 1) placebo med moderat intensitet livsstilsintervention (som brugt i TRIN 1); eller 2) semaglutid 2,4 mg med samme livsstilsintervention. Alle forsøgspersoner vil modtage 60 ugers forsøgsprodukt, som vil blive optitreret over 16 uger i dem, der er tildelt semaglutid 2,4 mg. De vil gennemføre vurderinger af energiindtag, appetit, madbelønning, humør, symptomer på spiseforstyrrelser og antropomorfe målinger ved baseline (uge 0) og uge 20, 40 og 60.

Det primære formål med det indledende langtidsbehandlingsforsøg vil være at sammenligne langtidseffekten af ​​semaglutid 2,4 mg vs placebo på ad libitum energiindtag under et frokostmåltid i uge 20, 40 og 60. Bekræftende sekundære mål vil teste effekten af ​​semaglutid 2,4 mg i uge 20, 40 og 60 på subjektive appetitvurderinger (både målt under en standardiseret morgenmad i laboratoriet og som oplevet mere globalt i løbet af den seneste uge), eksplicit madbelønning, målt med Power of Food Scale (24) og implicit madbelønning, målt med Leeds Food Preference Task (25, 26). Målinger af madtrang, humør, spiseforstyrrelsessymptomer og selvrapporterende mål for spiseadfærd vil blive betragtet som understøttende sekundære endepunkter og vil give yderligere bevis for medicinens sikkerhed og effekt.

Efter afslutningen af ​​undersøgelse 1 i uge 60 vil alle forsøgspersoner, der gennemfører en uge 60-vurdering og forbliver på lægemidlet, blive optaget i undersøgelse 2. Semaglutid-behandlede forsøgspersoner vil blive re-randomiseret (i et 1:4 semaglutid:placebo-forhold) til få semaglutid 2,4 mg eller placebo i 12 uger. Alle forsøgspersoner, der oprindeligt blev tildelt placebo, vil fortsætte med den medicin i yderligere 12 uger. Både forskere og forsøgspersoner vil forblive blinde over for forsøgspersoners originale og re-randomiserede (eller fortsatte) behandlingsopgaver. Målet med denne re-randomiserede medicintilbageholdelsesperiode vil være at sammenligne de 80 % af forsøgspersonerne, der oprindeligt blev tildelt semaglutid 2,4 mg, som fik placebo i uge 60 (semaglutid-til-placebo-gruppe) med de forsøgspersoner, der oprindeligt blev randomiseret til placebo (kontinuerlig placebo). gruppe) på alle primære og sekundære resultatmål i uge 72 (efter kontrol for undersøgelse 1 baseline/uge 0 værdier). Alle forsøgspersoner vil afslutte forsøgsproduktet i kumulativ uge 72 og vil vende tilbage til klinikken for et sidste sikkerhedsbesøg i uge 76.

Resultatvurderinger inklusive ad libitum energiindtag, subjektive mål for appetit, madbelønning, spiseadfærd, humør og symptomer på spiseforstyrrelser vil forekomme i uge 0, 20, 40 og 60 af undersøgelse 1 og i uge 12 (72 uger fra den oprindelige randomisering). ) af den re-randomiserede behandlingsperiode. Målinger af kropsvægt, taljeomkreds, blodtryk, puls og global, sidste uges appetit og madtrang (COEQ) vil også blive indsamlet hver 4. uge gennem begge behandlingsstudier.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

120

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania Center for Weight and Eating Disorders

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Mænd og kvinder, der melder om et ønske om at tabe sig
  2. I alderen 18-70 år
  3. Body mass index [BMI] ≥ 30 kg/m2 eller BMI ≥ 27 kg/m2 med en fedme-relateret komorbiditet (f.eks. behandlet eller ubehandlet hypertension, dyslipidæmi, obstruktiv søvnapnø eller hjerte-kar-sygdom)

  4. Kvalificerede kvindelige patienter vil være:

    • ikke-gravid, dokumenteret ved en negativ uringraviditetstest
    • ikke-lakterende
    • kirurgisk sterile eller postmenopausale, eller de vil acceptere at fortsætte med at bruge en accepteret præventionsmetode under undersøgelsen

  5. Fagene skal

    • Planlægger at blive i Philadelphia-området i de næste 1,5 år.
    • Evne til at give informeret samtykke før alle forsøgsrelaterede aktiviteter.

Ekskluderingskriterier:

  1. En diagnose af type I eller II diabetes
  2. Hæmoglobin A1c (HbA1c) > 6,5 %
  3. Ukontrolleret hypertension (blodtryk ≥ 160/100 mm Hg)
  4. Klinisk signifikant lever- (dvs. leverfibrose, cirrhose eller bekræftet NASH) eller nyresygdom
  5. Ukontrolleret skjoldbruskkirtelsygdom
  6. Oplevet en kardiovaskulær hændelse (f.eks. slagtilfælde, myokardieinfarkt) inden for de sidste 6 måneder, kongestiv hjertesvigt eller hjerteblokering større end første grad
  7. En historie med akut pancreatitis inden for de sidste 6 måneder
  8. Enhver historie med kronisk pancreatitis
  9. En anamnese med malignitet (bortset fra ikke-melanom hudkræft) inden for de sidste 5 år
  10. En personlig eller familiehistorie med medullær skjoldbruskkirtelkræft eller multipel endokrin neoplasi syndrom type 2
  11. En selvrapporteret ændring i kropsvægt >5 kg (11 lbs) inden for 90 dage før screening
  12. Brugt inden for de sidste 6 måneder medicin, der vides at give vægttab/øgning (f.eks. medicin godkendt til vægttab, orale steroider, antipsykotisk medicin) eller enhver GLP-1-receptoragonist.
  13. Kendt eller mistænkt allergi eller overfølsomhed over for forsøgsmedicin(er), hjælpestoffer eller relaterede produkter
  14. Modtagelse af ethvert forsøgslægemiddel inden for 6 måneder før dette forsøg
  15. Ansøgere med aktuel svær svær depressiv lidelse (BDI-II score ≥ 29 eller Patient Health Questionnaire-9 [PHQ-9] score > 15) eller svær angstlidelse
  16. Ansøgere med aktuelle, aktive selvmordstanker og/eller et selvmordsforsøg inden for det seneste år (sådanne personer vil blive henvist til psykiatrisk behandling, hvis de ikke tidligere har modtaget det).
  17. Enhver sværhedsgrad af psykotisk eller bipolar lidelse
  18. Bulimia nervosa diagnose inden for de seneste 5 år
  19. Selvrapporteret alkohol- eller stofmisbrug inden for de seneste 6 måneder, inklusive risikodrikke (aktuelt forbrug på ≥ 14 alkoholholdige drikkevarer om ugen)
  20. Historie om (eller planlægger at modtage inden for de næste 1,5 år) fedmekirurgi eller en vægttabsanordning. (Følgende vil dog være tilladt: fedtsugning eller abdominoplastik > 1 år før screening, laparoskopisk bånd, hvis fjernet > 1 år før screening, intragastrisk ballon eller aspire assist, hvis fjernet > 1 år før screening.)
  21. Manglende evne til at gå 5 blokke eller mere (behageligt) eller deltage i en anden form for aerob aktivitet.
  22. Kvinder, der ammer, er gravide eller planlægger at blive gravide inden for de næste 1,5 år eller ikke bruger passende præventionsforanstaltninger
  23. Tidligere deltagelse i dette forsøg (f.eks. randomiseret, men undlod at deltage)
  24. Ændringer af enhver kronisk medicin (type eller dosering) inden for de seneste 3 måneder.
  25. Fødevareallergi eller diætpræferencer, der ville forhindre individet i at indtage standard morgenmad eller ad libitum frokost.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Behavioral Treatment + Placebo (weeks 0-60) // Continuous Placebo (weeks 60-72)

Behavioral treatment (lifestyle modification counseling for weight loss) plus placebo from weeks 0 - 60.

At week 60, all placebo-treated participants were (sham) re-randomized to continue placebo for an additional 12 weeks (i.e., continuous placebo group).
Adfærdsmæssigt: Adfærdsbehandling
Alle deltagere, uanset medicintildeling, vil modtage det samme 60-ugers adfærdsmæssige vægttabsprogram. Korte (15-minutters), individuelle livsstilsrådgivningssessioner vil blive leveret af en psykolog, adfærdssundhedsrådgiver eller registreret diætist (eller anden uddannet sundhedsplejerske) i uge 0 (dvs. baseline/randomisering), 2, 4 og hver fjerde. uge fra uge 4 til uge 60 (17 sessioner) af undersøgelse 1. Forsøgspersonerne vil blive instrueret i at indtage en selvvalgt kost på 1200-1500 kcal/dag (for dem, der vejer < 250 lb) eller 1500-1800 kcal/dag ( for dem, der vejer ≥250 lb). De vil blive instrueret i at engagere sig i lav til moderat intensitet fysisk aktivitet (f.eks. gåture), gradvist opbygge til et mål på ≥150 minutter om ugen (fordelt over 5 dage) i uge 40. De vil blive instrueret i at bruge kalorietælling og selvovervågning for at nå deres mål.
Andre navne:
  • Livsstilsændring
  • Adfærdsmæssigt vægttab
  • Livsstilsintervention
Medicin: Placebo
En inaktiv saltvandsopløsning administreret via subkutan injektion
Andre navne:
  • Placebo for medicin
Aktiv komparator: Behavioral Treatment + Medication (weeks 0-60) // Switched to Placebo (weeks 60-72)

Behavioral treatment (lifestyle modification counseling for weight loss) plus semaglutide from weeks 0 to week 60.

At week 60, semaglutide-treated participants were re-randomized 4:1 to either switch to placebo or continue semaglutide for an additional 12 weeks (weeks 60 - 72). By re-allocating a small number of subjects to semaglutide-to-semaglutide at week 60, both researchers and subjects remain blinded to medication condition during the re-randomized treatment period. However, the semaglutide-to-semaglutide group was not intended to be subject to statistical analysis. Therefore the week 72 results for this group represent those of the semaglutide-to-placebo group who took semaglutide for 60 weeks and then placebo for the last 12 weeks.
Adfærdsmæssigt: Adfærdsbehandling
Alle deltagere, uanset medicintildeling, vil modtage det samme 60-ugers adfærdsmæssige vægttabsprogram. Korte (15-minutters), individuelle livsstilsrådgivningssessioner vil blive leveret af en psykolog, adfærdssundhedsrådgiver eller registreret diætist (eller anden uddannet sundhedsplejerske) i uge 0 (dvs. baseline/randomisering), 2, 4 og hver fjerde. uge fra uge 4 til uge 60 (17 sessioner) af undersøgelse 1. Forsøgspersonerne vil blive instrueret i at indtage en selvvalgt kost på 1200-1500 kcal/dag (for dem, der vejer < 250 lb) eller 1500-1800 kcal/dag ( for dem, der vejer ≥250 lb). De vil blive instrueret i at engagere sig i lav til moderat intensitet fysisk aktivitet (f.eks. gåture), gradvist opbygge til et mål på ≥150 minutter om ugen (fordelt over 5 dage) i uge 40. De vil blive instrueret i at bruge kalorietælling og selvovervågning for at nå deres mål.
Andre navne:
  • Livsstilsændring
  • Adfærdsmæssigt vægttab
  • Livsstilsintervention
Medicin: Semaglutid 2,4 MG/0,75 ML subkutan opløsning [WEGOVY]
Semaglutid 2,4 mg er en en gang ugentlig subkutan glukagon-lignende peptid-1 (GLP-1) receptoragonist, der er blevet godkendt af FDA til vægttab
Andre navne:
  • Wegovy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study 1 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Primary outcome (Study 1)
S1: Change from baseline to weeks 20, 40, and 60
Study 2 Ad Libitum Energy Intake (kcal) During a Buffet Lunch Meal (4 Hrs After Standardized Breakfast)
Tidsramme: S2: Endpoint comparison at week 72
Primary outcome (Study 2)
S2: Endpoint comparison at week 72

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Secondary confirmatory outcome (Study 1): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.
S1: Change from baseline to weeks 20, 40, and 60
Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) When Fasting
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured when fasting prior to eating a standardized breakfast. Score range 0-100 mm. Higher values indicate greater suppression (i.e., less appetite).
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Laboratory-based Appetite Measured as a Composite of Visual Analogue Scale Ratings (Hunger, Fullness, Satiety, Prospective Consumption) After Eating (Area Under the Curve)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): This is a single value calculated by averaging 100-mm VAS ratings for hunger (reversed), fullness, satiety, and prospective food consumption (reversed) as measured every 30 minutes in the 4 hours after eating a standardized breakfast. Post-prandial scores were combined into a single area under the curve value using the trapezoidal method. Possible area range: 0 - 24,000. Higher values indicate greater suppression (i.e., less appetite).
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Hunger as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): Visual analogue scale rating of hunger during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater hunger.
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Fullness After Meals as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): Visual analogue scale rating of fullness after meals during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater fullness after meals.
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Past-week Food Preoccupation as Measured Using the Control of Eating Questionnaire (COEQ)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): Visual analogue scale rating of food preoccupation during the past week (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater food preoccupation.
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Explicit Responsiveness to the Food Environment (Power of Food Scale 15-item Version)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): Explicit responsiveness to the food environment measured by the summary score of the Power of Food Scale (15-item version). Score range 1-5. Higher scores indicate greater responsiveness to the food environment.
S2: Week 72 endpoint controlling for S1 baseline
Study 2 Implicit Food Wanting of High-fat, Savory Foods Measured Using the Leeds Food Preference Task
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Secondary confirmatory outcome (Study 2): Implicit food wanting of high-fat, savory foods measured using the Leeds Food Preference Task. Scores range from -100 to +100 with higher scores indicating a greater implicit wanting of high-fat savory foods.
S2: Week 72 endpoint controlling for S1 baseline

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Study 1 Body Weight (kg)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Body weight change (kg)
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving Control Over the Past Week as Measured by the COEQ
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving control (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate greater ability to control food cravings.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving for Savory Over the Past Week as Measured by the COEQ
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for savory foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for savory foods.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Craving for Sweet Over the Past Week as Measured by the COEQ
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Composite (mean) of visual analogue scale ratings for craving for sweet foods (Control of Eating Questionnaire; COEQ). Score range 0-100 mm. Higher scores indicate stronger/more frequent cravings for sweet foods.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Food Cravings as Measured by the General Food Cravings Questionnaire - Trait
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Food cravings as measured by the General Food Cravings Questionnaire - Trait (G-FCQ-T 21-item). Score range 21-126, higher scores indicate more/stronger food cravings.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Explicit Liking of High-fat Savory Foods (LFPT)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1) Explicit liking of high-fat savory foods as measured on 100-mm VAS scales (mean of high-fat savory items) during the Leeds Food Preference Task. Score range 0 - 100 mm with higher scores indicating greater liking of high-fat savory foods.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Cognitive Restraint (Eating Inventory)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Eating behavior - cognitive restraint subscale of the Eating Inventory (EI). Score range 0-21, higher=more dietary restraint.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Disinhibition (Eating Inventory)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Eating behavior - disinhibition subscale of the Eating Inventory. Score range 0-16, higher=more disinhibition.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Weight-related Self-efficacy
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1) Mean score on the Weight-related self-efficacy (WEL-short form). Sum of 8 items, score range 0-80, higher scores indicate greater weight-related self-efficacy.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Mood as Assessed Using the PHQ-9
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Depressed mood as assessed using the PHQ-9. Score range 0 - 27; higher scores indicate more symptoms of depressed mood.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Clinician-rated Binge Eating Frequency (Sum of Objective and Subjective Binge Eating Frequency)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Clinician-rated binge eating frequency (sum of objective and subjective binge eating frequency) in the past 12 weeks as assessed by the Eating Disorder Examination (EDE). Score is the count of binge episodes, range ≥0, more episodes indicates more frequent binge eating in the past 12 weeks.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Self-reported Loss-of-control Eating (Loss of Control Eating Scale)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Self-reported loss-of-control eating as measured by the Loss of Control Eating Scale (LOCES). Mean score range 1-5; higher scores indicate greater/more frequent loss of control over eating.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Food Addiction Symptoms Measured by Yale Food Addiction Scale
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Exploratory outcome (Study 1): Food addiction symptoms measured by Yale Food Addiction Scale (YFAS). Symptom number range 0-11, higher scores indicate more food addiction symptoms
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Drive for Thinness (Eating Disorder Inventory [EDI])
Tidsramme: Change from baseline to weeks 20, 40, and 60
Supportive secondary outcome (Study 1): Study 1 Drive for thinness as measured by the Eating Disorder Inventory (EDI). Score range 0-28; higher scores indicate greater drive for thinness.
Change from baseline to weeks 20, 40, and 60
Study 1 Ratings of Nausea When Fasting
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Exploratory outcome (Study 1): Ratings of nausea using 100 mm visual analogue scales when fasting in the laboratory prior to consuming the standard breakfast meal. Score range 0-100 mm; higher scores indicate greater nausea.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Ratings of Food Palatability
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Exploratory outcome (Study 1): Ratings of food palatability using 100 mm visual analogue scales during a laboratory test meal. Score range 0-100 mm; higher scores indicate higher liking of the food taste.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Body Image Dissatisfaction (Body Satisfaction Scale)
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Exploratory outcome (Study 1): Body image dissatisfaction (Body Satisfaction Scale). Mean of 13 items, score range 1-7, higher scores indicate greater body part dissatisfaction.
S1: Change from baseline to weeks 20, 40, and 60
Study 1 Weight-related Self Stigmatization
Tidsramme: S1: Change from baseline to weeks 20, 40, and 60
Exploratory outcome (Study 1): Weight-related self stigmatization by the Weight Bias Internalization Scale. Mean of 11 items; score range 1-7; higher scores indicate greater weight-related self-stigmatization.
S1: Change from baseline to weeks 20, 40, and 60
Study 2 Body Weight (kg)
Tidsramme: S2: Week 72 endpoint controlling for S1 baseline
Supportive secondary outcome (Study 2): Body weight (kg) at week 72
S2: Week 72 endpoint controlling for S1 baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Samarbejdspartnere

Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. juli 2022

Primær færdiggørelse (Faktiske)

12. maj 2025

Studieafslutning (Faktiske)

12. maj 2025

Datoer for studieregistrering

Først indsendt

14. september 2022

Først indsendt, der opfyldte QC-kriterier

19. september 2022

Først opslået (Faktiske)

21. september 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 850370

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner