A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Description

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Conditions

Type 2 Diabetes (T2D)

Study Overview

Study Details

Study overview

The study will look at how well different doses of a new medicine called NNC0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. Participants will either get NNC0487-0111, which is given as tablets or as injections, or placebo. Which treatment the participant get is decided by chance.The study will last for about 43 weeks.

Safety and Efficacy of Once-weekly Subcutaneous and Once-daily Oral NNC0487-0111 in Participants With Type 2 Diabetes - a Dose Finding Study

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

Condition
Type 2 Diabetes (T2D)
Intervention / Treatment

-

Contacts and Locations

Santa Ana

Southern Cal Clinical Research, Santa Ana, California, United States, 92701

Santa Ana

Southern California Dermatology, Santa Ana, California, United States, 92701

Waterbury

Chase Medical Research LLC, Waterbury, Connecticut, United States, 06708

Waterbury

Chase Medical Research LLC, Waterbury, Connecticut, United States, 06708

Fleming Island

Fleming Island Ctr for Clin Res, Fleming Island, Florida, United States, 32003

Fleming Island

Fleming Island Ctr for Clin Res, Fleming Island, Florida, United States, 32003

Miramar

South Broward Research LLC, Miramar, Florida, United States, 33027

Miramar

South Broward Research LLC, Miramar, Florida, United States, 33027

Orlando

Florida Inst For Clin Res, Orlando, Florida, United States, 32825

Orlando

Florida Inst For Clin Res, Orlando, Florida, United States, 32825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent.
  • * Diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening.
  • * Stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without SGLT2 inhibitor.
  • * HbA1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening.
  • * Body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2.
  • * Able and willing to adhere to the protocol including wearing a continuous glucose monitoring (CGM) device provided for the study, as judged by the investigator.
  • * Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
  • * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novo Nordisk A/S,

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

2025-10-24