DRUG
NNC0487-0111 subcutanous
NNC0487-0111 administered subcutanously (under the skin)
Status
Completed
Phase
Phase 2
Enrollment
448
Locations
119
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
NNC0487-0111 administered subcutanously (under the skin)
DRUG
NNC0487-0111 placebo administered subcutanously (under the skin)
DRUG
NNC0487-0111 administered orally (in the mouth)
DRUG
NNC0487-0111 placebo administered orally (in the mouth)
Timeline
First posted
Aug 7, 2024
Study start
Aug 7, 2024
Primary completion
Oct 1, 2025
Study completion
Oct 24, 2025
Results posted
Not reported
Registry updated
Dec 29, 2025
Outcomes
Change in HbA1c
Time frame · From baseline (week 0) to end of treatment (week 36)
percent point
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 36)
percent
Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 36)
kg
Change in fasting plasma glucose (FPG)
Time frame · From baseline (week 0) to end of treatment (week 36)
mmol/L
CGM: Change in time in range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL)
Time frame · From baseline (week 0) to end of treatment (week 36)
percent points
Change in body mass index (BMI)
Time frame · From baseline (week 0) to end of treatment (week 36)
kg/m\^2
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 36)
cm
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 36)
mmHg
Change in average 24-hour systolic blood pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 36)
mmHg
Change in high sensitivity C-Reactive Protein (hsCRP)
Time frame · From baseline (week 0) to end of treatment (week 36)
Ratio to baseline
Change in total cholesterol
Time frame · From baseline (week 0) to end of treatment (week 36)
Ratio to baseline
Eligibility
Inclusion 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. Exclusion Criteria: * 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.
Study locations
Bulgaria · Croatia · Germany · Greece · Hungary · Japan · Poland · Romania · Slovakia · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
Southern Cal Clinical Research
Santa Ana, California, United States
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
Publications
No PMID-linked publications were present in this registry snapshot.
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