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Study of oral and injectable NNC0487-0111 (Amycretin) to find the best dose for blood sugar control in adults with type 2 diabetes taking metformin with or without SGLT2 inhibitor

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates a new medication called NNC0487-0111 for treating people with Type 2 Diabetes. The study aims to determine how different doses of this medication, given either as a weekly injection under the skin or as a daily tablet, affect blood sugar levels in patients whose diabetes is not well controlled with current treatments. The medication being tested is a special type of protein that works by targeting specific receptors in the body that help regulate blood sugar.

During the study, participants will receive either NNC0487-0111, placebo, or standard diabetes medications including metformin and a type of medication called SGLT2 inhibitor (dapagliflozin). The treatment period will last for 36 months, during which participants will need to wear a special device that continuously monitors their blood sugar levels.

The study will measure several health indicators, including changes in blood sugar control (HbA1c), body weight, blood pressure, and various blood tests. Researchers will also monitor kidney function and check for any side effects of the treatment. This research will help determine the most effective and safe dose of the new medication for future use in treating diabetes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial phase

    You will start taking your current metformin medication, with or without SGLT2 inhibitor.

    Your blood sugar levels will be monitored through a special device called continuous glucose monitoring (CGM) that you need to wear throughout the study.

  2. Step 2

    Treatment period

    You will receive one of the following treatments:

    - Weekly injection under the skin of NNC0487-0111 medicine

    - Daily oral tablet of NNC0487-0111 medicine

    - Placebo (a substance that looks like the medicine but contains no active ingredient)

    The treatment period will last for 36 weeks.

  3. Step 3

    Monitoring period

    Throughout the 36-week period, several health measurements will be taken:

    - Blood sugar levels (HbA1c)

    - Body measurements (weight, waist size, body mass index)

    - Blood pressure

    - Blood tests for cholesterol and other markers

    - Urine tests to check kidney function

  4. Step 4

    Safety monitoring

    Any side effects or health changes will be recorded throughout the study period.

    Regular check-ups will be conducted to ensure your safety and monitor your response to the treatment.

  5. Step 5

    Study completion

    The study is expected to end by October 31, 2025.

    Final health assessments will be conducted to evaluate the overall effects of the treatment.

Who can join the trial?

6 criteria

  • Age between 18 and 75 years old at the time of signing consent to participate in the study
  • Have been diagnosed with type 2 diabetes for at least 180 days (6 months) before screening
  • Taking stable doses of diabetes medications for at least 90 days before screening: - Metformin (a common diabetes medication) - With or without SGLT2 inhibitor (a medication that helps lower blood sugar)
  • Have a HbA1c level (a blood test that measures average blood sugar over the past 3 months) between 7.0% and 10.0%
  • Have a body mass index (BMI) between 23.0 and 50.0 kg/m2 (BMI is a measure of body fat based on height and weight)
  • Be willing and able to: - Follow the study protocol - Wear a continuous glucose monitoring (CGM) device (a small sensor that continuously measures blood sugar levels)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Diagnosis other than Type 2 Diabetes
  • Not currently taking metformin (a common diabetes medication)
  • Pregnant or breastfeeding women
  • Current participation in other clinical trials
  • History of severe allergic reactions to medications
  • Serious heart, kidney, or liver problems
  • Uncontrolled high blood pressure
  • History of diabetic ketoacidosis (a serious complication where the body produces high levels of blood acids)
  • Use of insulin therapy
  • History of pancreatic disease
  • Severe obesity
  • Active cancer or cancer treatment
  • Substance abuse within the past year
  • Mental health conditions that could interfere with study participation
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Investigated drugs

  • NNC0487-0111

    is an investigational medication being tested in two forms - as a weekly injection under the skin (subcutaneous) and as a daily oral pill. This medication is being studied for treating type 2 diabetes in patients whose blood sugar is not well controlled with their current treatment.

  • Metformin

    is a common oral medication used as a first-line treatment for type 2 diabetes. It helps control blood sugar levels by reducing the amount of glucose produced by the liver and improving how the body responds to insulin.

  • SGLT2 inhibitors

    are a class of diabetes medications that work by helping the kidneys remove excess sugar from the blood through urination. These medications can be used alongside metformin to help manage blood sugar levels in people with type 2 diabetes.

What is already known about the treatment

NNC0487-0111 - An investigational medication being studied for Type 2 Diabetes treatment, available in two formulations: once-weekly subcutaneous injection and once-daily oral tablet. This novel compound is currently undergoing clinical trials to evaluate its safety and efficacy in patients who have inadequate blood sugar control despite using metformin with or without SGLT2 inhibitors. The medication is being tested at various dose levels to establish the optimal dose-response relationship for reducing HbA1c (a measure of blood sugar control) over a 36-week treatment period. While the exact molecular mechanism is not specified in the trial data, this drug represents a new approach in diabetes management, offering potential flexibility in administration methods for patients with Type 2 Diabetes.

Investigated diseases

Type 2 Diabetes - A chronic metabolic disorder characterized by high blood sugar levels due to the body's ineffective use of insulin or reduced insulin production. The condition typically develops gradually, with the pancreas initially producing more insulin to compensate for insulin resistance. Over time, the body becomes less able to process glucose effectively, leading to elevated blood sugar levels. The disease often develops in adults and is frequently associated with excess body weight and physical inactivity. Common symptoms include increased thirst, frequent urination, fatigue, blurred vision, and slow healing of wounds.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509412-28-00Protocol codeNN9490-7678Estimated enrolment439 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).