Current partner codePEPTIDESDE
NCT06542874·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

448

Locations

119

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

NNC0487-0111 subcutanous

NNC0487-0111 administered subcutanously (under the skin)

DRUG

Placebo (NNC0487-0111 subcutanous)

NNC0487-0111 placebo administered subcutanously (under the skin)

DRUG

NNC0487-0111 oral

NNC0487-0111 administered orally (in the mouth)

DRUG

Placebo (NNC0487-0111 oral)

NNC0487-0111 placebo administered orally (in the mouth)

Timeline

From registration to results.

  1. First posted

    Aug 7, 2024

  2. Study start

    Aug 7, 2024

  3. Primary completion

    Oct 1, 2025

  4. Study completion

    Oct 24, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Dec 29, 2025

Outcomes

What the study measures.

Primary outcomes

Change in HbA1c

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

percent point

Secondary outcomes

Relative change in body weight

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

percent

Change in body weight

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

kg

Change in fasting plasma glucose (FPG)

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

mmol/L

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

Change in body mass index (BMI)

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

kg/m\^2

Change in waist circumference

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

cm

Change in systolic blood pressure (SBP)

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

mmHg

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

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

mmHg

Change in high sensitivity C-Reactive Protein (hsCRP)

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

Ratio to baseline

Change in total cholesterol

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

Ratio to baseline

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

119 registered sites.

Bulgaria · Croatia · Germany · Greece · Hungary · Japan · Poland · Romania · Slovakia · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

Southern Cal Clinical Research

Santa Ana, California, United States

Chase Medical Research LLC

Waterbury, Connecticut, United States

Fleming Island Ctr for Clin Res

Fleming Island, Florida, United States

Encore Medical Research LLC

Hollywood, Florida, United States

South Broward Research LLC

Miramar, Florida, United States

Florida Inst For Clin Res

Orlando, Florida, United States

Cedar-Crosse Research Center

Chicago, Illinois, United States

Advanced Internal Medicine, PLLC

Paducah, Kentucky, United States

Medstar Research Institute_Hyattsville

Hyattsville, Maryland, United States

MD Medical Research

Oxon Hill, Maryland, United States

Arcturus HC PLC Troy Med Res

Troy, Michigan, United States

Arcturus Healthcare, PLC

Troy, Michigan, United States

Clinical Research Professionals

Chesterfield, Missouri, United States

AMC Community Endocrinology

Albany, New York, United States

Lucas Research Inc.

Morehead City, North Carolina, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Plains Clinical Research Center, LLC_Fargo

Fargo, North Dakota, United States

Preferred Primary Care Physicians_Pittsburgh

Pittsburgh, Pennsylvania, United States

Health Concepts

Rapid City, South Dakota, United States

Clinical Research Associates

Nashville, Tennessee, United States

MidState Endocrine Associates

Nashville, Tennessee, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

Victorium Clinical Research

Houston, Texas, United States

Synergy Groups Medical

Houston, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Amycretin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.