Amaze 10: Testing NNC0487-0111 for Weight Loss in Japan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, double-blind trial comparing NNC0487-0111 to placebo in adults with excess body weight in Japan. Eligible participants include adults 18 and older, with or without type 2 diabetes, and with knee osteoarthritis for a subset. Participants are assigned by chance to receive either the study drug or placebo for a defined period, alongside standard care. The study aims to assess safety and weight loss effect, with outcomes measured by weight change and metabolic parameters. The medicine being studied is not yet widely prescribed outside this trial.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shinsapporo Seiryou Hospital_General Clinical Department
  Sapporo, Hokkaido, Japan Recruiting
• Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
  Chigasaki-shi, Kanagawa, Japan, Japan Recruiting
• TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
  Aichi, Japan Recruiting
• Akaicho Clinic_Internal medicine
  Chiba-shi, Chiba, Japan Recruiting
• Suidoubashi Medical Clinic_Internal Medicine
  Chiyoda-ku, Tokyo, Japan Recruiting
• Tokyo Asbo Clinic_Internal Medicine
  Chuo-ku, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.