Recruiting
Phase 3

NNC0487-0111

Sponsor:

Novo Nordisk A/S

Code:

NCT07533175

Conditions

Diabetes Mellitus

Overweight

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NNC0487-0111

Placebo (matched to NNC0487-0111)

Study Details

Brief summary:

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

Study ID

NCT07533175

Start date

Apr 13, 2026

Status verified date

Sep, 2026

Completion date

Aug 7, 2028

Anticipated

Primary completion date

Aug 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

630 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

Interventions

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 (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.

Primary outcome measure

  • Relative change in body weight [ Time Frame: From baseline (week 0) to (week 84) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Univ of Alabama Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Torrance Clinical Research Institute, Inc.

Recruiting

Lomita, California, United States, 90717

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Northeast Research Institute

Recruiting

Fleming Island, Florida, United States, 32003

Jacksonville Ctr Clin Res

Recruiting

Jacksonville, Florida, United States, 32216

Florida Institute for Clinical Research, LLC

Recruiting

Orlando, Florida, United States, 32825

Oviedo Medical Research, LLC

Recruiting

Oviedo, Florida, United States, 32765

International Diabetes Center

Recruiting

Minneapolis, Minnesota, United States, 55416

Southgate Medical Group, LLP

Recruiting

West Seneca, New York, United States, 14224

Spartanburg Medical Research

Recruiting

Spartanburg, South Carolina, United States, 29303

M3 Wake Research Chattanooga

Recruiting

Chattanooga, Tennessee, United States, 37421

UT Southwestern Med Center

Recruiting

Dallas, Texas, United States, 75390

PlanIt Research, PLLC

Recruiting

Houston, Texas, United States, 77079

National Clin Res Inc.

Recruiting

Richmond, Virginia, United States, 23294

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-09-04.