A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes
Completed · Phase 2 · Has a placebo group
Conditions studied: Type 2 Diabetes (T2D)
In brief
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.
Key facts
- Study ID
- NCT06542874
- Run by
- Novo Nordisk A/S
- People needed
- 448
- Starts
- 2024-08-07
- Expected to finish
- 2025-10-24
- Last updated by the study team
- 2025-12-29
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Chase Medical Research LLC — Waterbury, Connecticut, United States
- Fleming Island Ctr for Clin Res — Fleming Island, Florida, United States
- Encore Medical Research LLC — Hollywood, Florida, United States
- South Broward Research LLC — Miramar, Florida, United States
- Florida Inst For Clin Res — Orlando, Florida, United States
- Cedar-Crosse Research Center — Chicago, Illinois, United States
- Advanced Internal Medicine, PLLC — Paducah, Kentucky, United States
- Medstar Research Institute_Hyattsville — Hyattsville, Maryland, United States
- MD Medical Research — Oxon Hill, Maryland, United States
- Arcturus HC PLC Troy Med Res — Troy, Michigan, United States
- Arcturus Healthcare, PLC — Troy, Michigan, United States
- Clinical Research Professionals — Chesterfield, Missouri, United States
- AMC Community Endocrinology — Albany, New York, United States
- Lucas Research Inc. — Morehead City, North Carolina, United States
- Piedmont Healthcare/Research — Statesville, North Carolina, United States
- Plains Clinical Research Center, LLC_Fargo — Fargo, North Dakota, United States
- Preferred Primary Care Physicians_Pittsburgh — Pittsburgh, Pennsylvania, United States
- Health Concepts — Rapid City, South Dakota, United States
- Clinical Research Associates — Nashville, Tennessee, United States
- MidState Endocrine Associates — Nashville, Tennessee, United States
- Velocity Clinical Res-Dallas — Dallas, Texas, United States
- Victorium Clinical Research — Houston, Texas, United States
- Synergy Groups Medical — Houston, Texas, United States
- PlanIt Research, PLLC — Houston, Texas, United States
- Southern Cal Clinical Research — Santa Ana, California, United States
Full record on ClinicalTrials.gov
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