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Completed

NCT Number: NCT06542874

A Research Study Comparing How Well Different Doses of the Medicine NNC0487-0111 Lower Blood Sugar in People With Type 2 Diabetes

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IPSOMC Dr. Miglena Rizova Ltd., Kyustendil, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NNC0487-0111 subcutanous

Drug

NNC0487-0111 administered subcutanously (under the skin)

Placebo (NNC0487-0111 subcutanous)

Drug

NNC0487-0111 placebo administered subcutanously (under the skin)

NNC0487-0111 oral

Drug

NNC0487-0111 administered orally (in the mouth)

Placebo (NNC0487-0111 oral)

Drug

NNC0487-0111 placebo administered orally (in the mouth)

Primary outcomes

  1. Change in HbA1c

    Time frame: From baseline (week 0) to end of treatment (week 36)

    percent point

Secondary outcomes

  1. Relative change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 36)

    percent

  2. Change in body weight

    Time frame: From baseline (week 0) to end of treatment (week 36)

    kg

  3. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    mmol/L

  4. 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

  5. Change in body mass index (BMI)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    kg/m^2

  6. Change in waist circumference

    Time frame: From baseline (week 0) to end of treatment (week 36)

    cm

  7. Change in systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    mmHg

  8. Change in average 24-hour systolic blood pressure (SBP)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    mmHg

  9. Change in high sensitivity C-Reactive Protein (hsCRP)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  10. Change in total cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  11. Change in high-density lipoprotein (HDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  12. Change in low-density lipoprotein (LDL) cholesterol

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  13. Change in triglycerides

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  14. Number of adverse events

    Time frame: From baseline (week 0) to end of study (week 40)

    Count of events

  15. Change in Urinary Albumin/Creatinine Ratio (UACR)

    Time frame: From baseline (week 0) to end of treatment (week 36)

    Ratio to baseline

  16. Participant without macroalbuminuria (UACR < 300 mg/g) at baseline (week 0) developing (yes/no) new onset of macroalbuminuria (UACR ≥ 300 mg/g)

    Time frame: At end of treatment (week 36)

    Count of participant

  17. Change in eGFR creatinine- and cystatin C based CKD-EPI

    Time frame: From baseline (week 0) to end of treatment (week 36)

    mL/min/1.73 m^2

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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