How NNC0487-0111 affects insulin use and pancreas function in adults with type 2 diabetes

Effect of NNC0487-0111 on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

This study will test whether a new drug called NNC0487-0111 changes how the body uses insulin and how the pancreas works in adults with type 2 diabetes who are on stable metformin (with or without an SGLT2 inhibitor).

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Novo Nordisk A/S (Industry-sponsored)
• Locations: 1 site (Neuss)
• Trial ID: NCT07535307 on ClinicalTrials.gov

What this trial studies

This is a phase 1, randomized, placebo-controlled interventional study comparing NNC0487-0111 to placebo in adults with type 2 diabetes. Participants are adults aged 18–75 with a diabetes diagnosis of at least 180 days who are on stable metformin, with or without an SGLT2 inhibitor, and who meet protocol HbA1c limits. The study will measure how the body handles insulin and markers of pancreatic function after receiving the investigational drug or placebo. Safety, tolerability, and pharmacodynamic signals will guide further development decisions.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with type 2 diabetes diagnosed ≥180 days who are on a stable dose of metformin (and optionally an SGLT2 inhibitor) and who meet the study's HbA1c entry criteria.

Not a fit: People who are pregnant, have type 1 diabetes, are not on stable metformin (or have differing medications), or whose HbA1c falls outside the study ranges are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, the drug could lead to therapies that improve insulin handling and pancreatic function, potentially helping people with type 2 diabetes manage blood sugar better.

How similar studies have performed: This is an early-phase, mechanism-focused trial for a novel compound; while other early pharmacology studies in diabetes have sometimes shown promising signals, the specific approach with NNC0487-0111 is new and not yet proven in patients.

Eligibility criteria

Inclusion Criteria:

* Male or female.
* Age 18-75 years (both inclusive) at the time of signing the informed consent.
* Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
* Only stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for at least 90 days before screening. If additional oral antidiabetic drug (OAD) is required, only stable dose(s) of sodium-glucose cotransporter-2 inhibitors (SGLT2i) is permitted, and this must also have been maintained for at least 90 days before screening.
* HbA1c at screening of 6.5-9.5% \[48-80 millimole per mole (mmol/mol)\] (both inclusive) if on metformin only, or 6.0-9.0% (42-75 mmol/mol) (both inclusive) if on metformin in combination with SGLT2i.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Presence of type 1 diabetes.
* Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
* Treatment with any medication for the indication of T2D or weight management 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.
* Treatment with a GLP-1 receptor agonist.
* 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.
* Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days before screening.
* Renal impairment with estimated glomerular filtration rate (eGFR) less than (\<) 60.0 milliliter per minute per meter square (ml/min/1.73 m\^2) at screening.

Where this trial is running

Neuss

• Profil Institut für Stoffwechselforschung GmbH — Neuss, Germany (Recruiting)

Study contacts

• Study coordinator: Novo Nordisk

Conditions Diabetes Mellitus