NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07533175

RecruitingPhase 3

Sponsor: Novo Nordisk A/S

Conditions: Diabetes Mellitus, Overweight, Obesity

Interventions: NNC0487-0111, Placebo (matched to NNC0487-0111)

Countries: United States, Argentina, Brazil, Croatia, Hungary, Italy, Mexico, Romania

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (74)

Birmingham, Alabama, United States
Escondido, California, United States
Lomita, California, United States
Walnut Creek, California, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Oviedo, Florida, United States
Minneapolis, Minnesota, United States
West Seneca, New York, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Manuel Alberti, Buenos Aires, Argentina
Buenos Aires, Argentina
Córdoba, Argentina
Santa Fe, Argentina
Curitiba, Paraná, Brazil
Campinas, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Karlovac, Croatia
Krapinske Toplice, Croatia
Opatija, Croatia
Osijek, Croatia
Pula, Croatia
Solin, Croatia
Varaždin, Croatia
+ 44 more on CT.gov