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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

400

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Japan
      • Aichi, Japan, 468-0009
        • Rekruttering
        • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Har ikke rekruttert ennå
        • The University of Tokyo Hospital, Diabetes and Metabolic
      • Chiba, Japan, 261-0004
        • Har ikke rekruttert ennå
        • 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
        • Har ikke rekruttert ennå
        • Motomachi Takatsuka Naika Clinic_Internal Medicine
      • Kanagawa, Japan, 232-0064
        • Har ikke rekruttert ennå
        • Yokohama Minoru Clinic_Internal medicine
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • Har ikke rekruttert ennå
        • 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
        • Har ikke rekruttert ennå
        • 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
        • Har ikke rekruttert ennå
        • Morimoto Clinic_Pain Clinic
      • Tokyo, Japan, 160-0008
        • Rekruttering
        • ToCROM Clinic_Internal Medicine
      • Tokyo, Japan, 103-0027
        • Har ikke rekruttert ennå
        • 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
        • Har ikke rekruttert ennå
        • 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
        • Har ikke rekruttert ennå
        • Matsuba Clinic_Internal Medicine
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Har ikke rekruttert ennå
        • OCROM Clinic_Internal medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Legemiddel: Placebo (tilpasset NNC0487-0111)
Placebo som er tilpasset NNC0487-0111 vil bli administrert subkutant ved hjelp av ferdigfylte penn-injektorer til en av kroppsdeler: lår, mage eller overarm.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. september 2026

Primær fullføring (Antatt)

5. februar 2029

Studiet fullført (Antatt)

5. februar 2029

Datoer for studieregistrering

Først innsendt

10. september 2026

Først innsendt som oppfylte QC-kriteriene

10. september 2026

Først lagt ut (Faktiske)

16. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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