Skip to content
TrialMatch
Sign up
Recruiting Phase 3

AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight

Create a profile to match View the full record on ClinicalTrials.gov

About this study

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Condition
Diabetes Mellitus, Overweight, Obesity
Tested
NNC0487-0111, Placebo (matched to NNC0487-0111)
Sponsor
Novo Nordisk A/S

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Study condition: Diabetes Mellitus, Overweight, Obesity
  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing informed consent.
  • Diagnosed with type 2 diabetes mellitus more than equal to (≥) 180 days before screening.
  • Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label.
  • Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.
  • Haemoglobin A1c (HbA1c) 7-10% \[53-86 (millimoles per mole) mmol/mol\] (both inclusive) as measured by the central laboratory at screening.

Exclusion 7

  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than (\<) 30 milliliter per minute per meter square (mL/min/1.73 m\^2) \[2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\], at screening.
  • Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening.
  • Diabetic retinopathy or maculopathy must be verified by an eye examination performed 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.
  • 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.
  • 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.

Where

74 sites, 72 recruiting

Kynet Recoleta

Buenos Aires, Argentina

Recruiting

Centro médico privado Cemaic

Córdoba, Argentina

Recruiting

MICA- Medicina e Investigación Cardiometabólica

Manuel Alberti, Buenos Aires, Argentina

Recruiting

CEDIR - Centro de diagnóstico y rehabilitación Santa Fe

Santa Fe, Argentina

Recruiting

PUCCAMP - Hospital e Maternidade Celso Pierro

Campinas, São Paulo, Brazil

Recruiting

Cline Research Center

Curitiba, Paraná, Brazil

Recruiting

and 68 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.