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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT06542874 (opens ClinicalTrials.gov in a new tab)Other idNN9490-7678Other idU1111-1296-9708Other id2023-509412-28Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
448 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
11 countries

United States, Bulgaria, Croatia, Germany, Greece, Hungary, Japan, Poland, Romania, Slovakia, Spain

Start
7 Aug 2024
Primary completion
1 Oct 2025
Completion
24 Oct 2025
First posted
7 Aug 2024
Last update posted
2 Oct 2026
Conditions
Type 2 Diabetes (T2D)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 2

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

    NCT06542874

    7 Aug 2024 to 24 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111 subcutanousDrug
  • Placebo (NNC0487-0111 subcutanous)Drug
  • NNC0487-0111 oralDrug
  • Placebo (NNC0487-0111 oral)Drug

Arms11

  • Placebo comparator

    Placebo subcutaneous

    Placebo for subcutaneous treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 1

    NNC0487-0111 subcutaneous dose 1 treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 2

    NNC0487-0111 subcutaneous dose 2 treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 3

    NNC0487-0111 subcutaneous dose 3 treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 4

    NNC0487-0111 subcutaneous dose 4 treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 5

    NNC0487-0111 subcutaneous dose 5 treatment

  • Experimental

    NNC0487-0111 subcutaneous dose 6

    NNC0487-0111 subcutaneous dose 6 treatment

  • Placebo comparator

    Placebo oral

    Placebo for oral treatment

  • Experimental

    NNC0487-0111 oral dose 1

    NNC0487-0111 oral dose 1 treatment

  • Experimental

    NNC0487-0111 oral dose 2

    NNC0487-0111 oral dose 2 treatment

  • Experimental

    NNC0487-0111 oral dose 3

    NNC0487-0111 oral dose 3 treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c

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

    Registry description

    percent point

Secondary outcomes(17)

  1. Relative change in body weight

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

    Registry description

    percent

  2. Change in body weight

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

    Registry description

    kg

  3. Change in fasting plasma glucose (FPG)

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

    Registry description

    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)

    Registry description

    percent points

  5. Change in body mass index (BMI)

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

    Registry description

    kg/m\^2

  6. Change in waist circumference

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

    Registry description

    cm

  7. Change in systolic blood pressure (SBP)

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

    Registry description

    mmHg

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

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

    Registry description

    mmHg

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

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

    Registry description

    Ratio to baseline

  10. Change in total cholesterol

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

    Registry description

    Ratio to baseline

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

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

    Registry description

    Ratio to baseline

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

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

    Registry description

    Ratio to baseline

  13. Change in triglycerides

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

    Registry description

    Ratio to baseline

  14. Number of adverse events

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

    Registry description

    Count of events

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

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

    Registry description

    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)

    Registry description

    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)

    Registry description

    mL/min/1.73 m\^2

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

9 results

Efficacy and safety of once-weekly subcutaneous zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.

Mora et al. 2026Lancet (London, England)

PMID 42532080DOI 10.1016/s0140-6736(26)01248-1PUB-42532080

Full text at the publisher9 results
Publisher pageSee results (9)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2026

Corrected

Efficacy and safety of once-daily oral zenagamtide, a novel unimolecular GLP-1 and amylin receptor agonist, in adults with type 2 diabetes: a multicentre, randomised, parallel, double-blind, placebo-controlled, dose-finding, phase 2 trial.

Mora et al. 2026Lancet (London, England)cited by 1

PMID 42532079DOI 10.1016/s0140-6736(26)01247-xPUB-42532079

Full text at the publisher
Publisher pageRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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