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Comparing different doses of NNC0487-0111 for lowering blood sugar in type 2 diabetes

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

Phase 2 Interventional Novo Nordisk A/S · NCT06542874

This study is testing different doses of a new medication called NNC0487-0111 to see if it can help people with type 2 diabetes lower their blood sugar and lose weight.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment432 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations179 sites (Santa Ana, California and 178 other locations)
Trial IDNCT06542874 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of various doses of a new medication, NNC0487-0111, in reducing blood sugar levels and body weight in individuals with type 2 diabetes. Participants will be randomly assigned to receive either NNC0487-0111, administered as tablets or injections, or a placebo. The study will last approximately 43 weeks, during which the impact of the medication on blood sugar control will be closely monitored. Eligible participants must have a stable diabetes treatment regimen and meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of type 2 diabetes and specific health metrics, including stable medication use and a certain HbA1c range.

Not a fit: Patients who have recently changed their diabetes treatment or have other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for better blood sugar management in patients with type 2 diabetes.

How similar studies have performed: Previous studies have shown promise with similar approaches, but the specific medication NNC0487-0111 is novel and has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Santa Ana, California and 178 other locations

+129 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Type 2 Diabetes
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.