Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

AMAZE 10: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People in Japan With Excess Body Weight Lose Weight (AMAZE 10)

10. september 2026 opdateret af: Novo Nordisk A/S

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. Which treatment participants receive is decided by chance. NNC0487-0111 is a new medicine that doctors cannot yet prescribe, but it has been tested in humans before.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

400

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Japan
      • Aichi, Japan, 468-0009
        • Rekruttering
        • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Ikke rekrutterer endnu
        • The University of Tokyo Hospital, Diabetes and Metabolic
      • Chiba, Japan, 261-0004
        • Ikke rekrutterer endnu
        • Tokuyama clinic_Diabetic internal medicine
      • Chiba-shi, Chiba, Japan, 260-0804
        • Rekruttering
        • Akaicho Clinic_Internal medicine
      • Chiyoda-ku, Tokyo, Japan, 101-0065
        • Rekruttering
        • Suidoubashi Medical Clinic_Internal Medicine
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Rekruttering
        • Tokyo Asbo Clinic_Internal Medicine
      • Fukuoka-shi, Fukuoka, Japan, 814-0165
        • Rekruttering
        • Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine
      • Ibaraki, Japan, 311-0113
        • Rekruttering
        • Naka Kinen Clinic_Internal medicine
      • Kagawa, Japan, 765-0071
        • Rekruttering
        • Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine
      • Kamakura-shi, Kanagawa, Japan, 247 0056
        • Rekruttering
        • Takai Internal Medicine Clinic_Internal Medicine
      • Kanagawa, Japan, 231-0023
        • Ikke rekrutterer endnu
        • Motomachi Takatsuka Naika Clinic_Internal Medicine
      • Kanagawa, Japan, 232-0064
        • Ikke rekrutterer endnu
        • Yokohama Minoru Clinic_Internal medicine
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • Ikke rekrutterer endnu
        • JCHO Kyushu Hospital_Department of Endocrinology and Metabolism
      • Koriyama-shi, Fukushima, Japan, 963-8851
        • Rekruttering
        • Seino Internal Medicine Clinic_Internal medicine
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • Ikke rekrutterer endnu
        • National Hospital Organization Kyoto Medical Center_Diabetic Center
      • Osaka, Japan, 565-0871
        • Rekruttering
        • The University of Osaka Hospital_Metabolic Medicine
      • Osaka-shi, Osaka, Japan, 530-0041
        • Ikke rekrutterer endnu
        • Morimoto Clinic_Pain Clinic
      • Tokyo, Japan, 160-0008
        • Rekruttering
        • ToCROM Clinic_Internal Medicine
      • Tokyo, Japan, 103-0027
        • Ikke rekrutterer endnu
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 160-0004
        • Rekruttering
        • Clinical Research Hospital Tokyo_Internal medicine
      • Yao City, Osaka, Japan, 581-0011
        • Rekruttering
        • Yao Tokushukai General Hospital_Internal medicine
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 004-0004
        • Rekruttering
        • Shinsapporo Seiryou Hospital_General Clinical Department
    • Kanagawa
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Ikke rekrutterer endnu
        • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
    • Kanagawa, Japan
      • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
        • Rekruttering
        • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
      • Kawasaki-shi, Kanagawa, Japan, Japan, 212 0024
        • Ikke rekrutterer endnu
        • Matsuba Clinic_Internal Medicine
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Ikke rekrutterer endnu
        • OCROM Clinic_Internal medicine

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.
  • For participants with T2D at screening (max 25%), the following inclusion criteria apply
  • Diagnosed with T2D ≥ 180 days before screening.
  • Haemoglobin A1c (HbA1c) 7.0 -10.0% (53-86 millimole per mole (mmol/mol) (both inclusive) as measured by the central laboratory at screening.
  • Treatment with lifestyle intervention, and/or with 0-3 marketed oral antidiabetic drugs (OADs) (Metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors, α-glucosidase inhibitors, imeglimin, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with OADs should be stable (same drug(s), dose and dosing frequency) before screening.
  • For participants with knee OA at screening (approximately 50 participants), the following inclusion criteria apply
  • Clinical diagnosis of knee OA (American College of Rheumatology criteria) with radio-graphic changes (Kellgren-Lawrence grades 2 to 3 as per central reading) in the target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
  • Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
  • Willingness to complete a 72-hour washout period of analgesics before all visits in-volving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 gram/day is allowed as rescue medication up until 24 hours before those visits).

Exclusion Criteria:

- Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening.

For participants without T2D at screening (including participants with and without knee OA), the following exclusion criteria apply in addition to criterion 1 (above):

  • HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
  • History of type 1 or type 2 diabetes mellitus.
  • For participants with T2D at screening, the following exclusion criteria apply in addition to criterion 1 (above):
  • Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 m^2, (2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (by creatinine)), at screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening.
  • Diabetic retinopathy or maculopathy must be verified by an eye examination per-formed within 90 days before screening or in the period between screening and randomisation.
  • Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

For participants with knee OA, the following exclusion criteria apply in addition to cri-teria 1-3 (above):

  • Any joint prosthesis or joint replacement in the target knee.
  • Arthroscopy or injections into the target knee within the last 90 days prior to screening.
  • Any other joint disease in the target knee including gout and pseudogout.

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
Eksperimentel: NNC0487-0111
Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity.
Medicin: NNC0487-0111
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo komparator: NNC0487-0111 Placebo
Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Medicin: Placebo (matchet til NNC0487-0111)
Placebo, der matcher NNC0487-0111, vil blive administreret subkutant ved hjælp af fyldte pen-injektorer til en af følgende kropsdele: lår, mave eller overarm.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative change in body weight
Tidsramme: From baseline (week 0) to week 84
Measured as percentage of body weight (%).
From baseline (week 0) to week 84

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in waist circumference measured according to Japan society for the Study of Obesity (JASSO) guideline
Tidsramme: From baseline (week 0) to week 84
Measured as centimetre (cm).
From baseline (week 0) to week 84

Samarbejdspartnere og efterforskere

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

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

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)

7. september 2026

Primær færdiggørelse (Anslået)

5. februar 2029

Studieafslutning (Anslået)

5. februar 2029

Datoer for studieregistrering

Først indsendt

10. september 2026

Først indsendt, der opfyldte QC-kriterier

10. september 2026

Først opslået (Faktiske)

16. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN9490-8088
  • U1111-1313-7707 (Anden identifikator: World Health Organization (WHO))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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