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

Purpose

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.

Conditions

  • Diabetes Mellitus
  • Overweight
  • Obesity

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
NNC0487-0111 dose level 1 		Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Drug: 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.
Experimental
NNC0487-0111 dose level 2 		Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Drug: 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.
Experimental
NNC0487-0111 dose level 3 		Participants will be randomized to receive NNC0487-0111 dose level 3 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Drug: 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.
Experimental
NNC0487-0111 dose level 4 		Participants will be randomized to receive NNC0487-0111 dose level 4 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Drug: 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 Comparator
Placebo 		Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
  • Drug: Placebo (matched to NNC0487-0111)
    Placebo matched to NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Recruiting Locations

Univ of Alabama Birmingham
Birmingham, Alabama 35294

Headlands Research California, LLC
Escondido, California 92025

Torrance Clinical Research Institute, Inc.
Lomita, California 90717

Diablo Clinical Research, Inc.
Walnut Creek, California 94598

Northeast Research Institute
Fleming Island, Florida 32003

Jacksonville Ctr Clin Res
Jacksonville, Florida 32216

Florida Institute for Clinical Research, LLC
Orlando, Florida 32825

Oviedo Medical Research, LLC
Oviedo, Florida 32765

International Diabetes Center
Minneapolis, Minnesota 55416

Southgate Medical Group, LLP
West Seneca, New York 14224

Spartanburg Medical Research
Spartanburg, South Carolina 29303

M3 Wake Research Chattanooga
Chattanooga, Tennessee 37421

UT Southwestern Medical Center - Lingvay
Dallas, Texas 75390

PlanIt Research, PLLC
Houston, Texas 77079

National Clin Res Inc.
Richmond, Virginia 23294

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com