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.
Status
Not yet recruiting
Phase
Phase 3
Enrollment
1,000
Locations
120
Results
Not posted
Publications
0
Study 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. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance.
Interventions
DRUG
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUG
Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUG
Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUG
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Timeline
First posted
Feb 10, 2026
Study start
May 20, 2026
Primary completion
Dec 12, 2028
Study completion
Jan 26, 2029
Results posted
Not reported
Registry updated
Mar 12, 2026
Outcomes
Relative change in body weight
Time frame · From baseline (week 0) to week 84
Measured as percentage of body weight.
Change in waist circumference
Time frame · From baseline (week 0) to week 84
Measured as centimeter (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to week 84
Measured as millimeter of mercury (mmHg).
Change in body weight
Time frame · From baseline (week 0) to week 84 and week 104
Measured as kilograms (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to week 84 and week 104
Measured as kilograms per meter squared (kg/m\^2).
Number of participants with achievement of in haemoglobin A1c (HbA1c) < 7.0 percent (%) (yes/no)
Time frame · From baseline (week 0) to week 84
Measured as count of participants.
Number of participants with achievement of HbA1c ≤ 6.5% (yes/no)
Time frame · From baseline (week 0) to week 84
Measured as count of participants.
Number of participants with achievement of HbA1c < 5.7% (yes/no)
Time frame · From baseline (week 0) to week 84
Measured as count of participants.
Change in fasting plasma glucose (FPG) measured as millimole per liter (mmol/L)
Time frame · From baseline (week 0) to week 84
Measured as mmol/L.
Change in FPG measured as milligrams per deciliter (mg/dL)
Time frame · From baseline (week 0) to week 84
Measured as mg/dL.
Ratio to baseline: change in fasting insulin
Time frame · From baseline (week 0) to week 84
Measured as ratio.
Eligibility
Key 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 ≥ 180 days before screening. * Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at 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. Key Exclusion Criteria: * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (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) within 180 days before screening or are expected to require treatment within 180 days 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 randomization. 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 locations
Argentina · Brazil · Bulgaria · Croatia · Germany · Hungary · India · Mexico · Poland · Portugal · Romania · Thailand · Turkey (Türkiye) · United States. Showing up to 24 locations stored in the fast local snapshot.
Encore Medical Research LLC
Hollywood, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Endocrine Research Solutions, Inc
Roswell, Georgia, United States
Elite Clinical Trials
Blackfoot, Idaho, United States
Endo And Metab Cons
Rockville, Maryland, United States
Arcturus Healthcare, PLC.
Troy, Michigan, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Selma Medical Associates
Winchester, Virginia, United States
Centro de Investigaciones Metabólicas
Capital Federal, Buenos Aires, Argentina
Centro Médico CIMEL
Lanús Este, Buenos Aires, Argentina
Centro Médico Privado San Vicente Diabetes
Córdoba, Argentina
Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda.
Porto Alegre, Rio Grande do Sul, Brazil
i9 Pesquisas Clínicas
Campinas, São Paulo, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, Brazil
BR Trials - Ensaios Clínicos e Consultoria Ltda.
São Paulo, São Paulo, Brazil
Dr. Tatyana Metalova - AIPSMCE EOOD
Gotse Delchev, Bulgaria
Medical centre Zdrave 1 OOD
Kozloduy, Bulgaria
UMHAT Pulmed OOD - Pazardzhik, Department of Internal Diseases
Pazardzhik, Bulgaria
MHAT Heart and Brain EAD - Pleven, Endocrinology and Metabolic Diseases
Pleven, Bulgaria
DCC I- Pleven EOOD Endocrinology
Pleven, Bulgaria
MHAT Knyaginya Klementina - Sofia EAD
Sofia, Bulgaria
MHAT Sveta Sofia EOOD, Department of Endocrinology and Metabolic diseases
Sofia, Bulgaria
Publications
No PMID-linked publications were present in this registry snapshot.
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