DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07535307

RecruitingPhase 1

Investigating How NNC0487-0111 Regulates Insulin of Adults With Type 2 Diabetes

Effect of NNC0487-0111 on Insulin Sensitivity and Pancreatic Endocrine Function in Adults With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-9.5%

Primary endpoint

•M-value in Hyperinsulinaemic euglycaemic clamp (HEC)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07535307
Org study IDNN9490-8153
Secondary ID2025-521595-55European Medical Agency (EMA)
Secondary IDU1111-1320-4780World Health Organization (WHO)

Timeline

Milestones

Study start2026-04-10actual
Study first posted2026-04-17actual
Last update posted2026-04-24actual
Primary completion2027-11-11estimated
Study completion2027-12-06estimated

Assets

Investigational agents

Amycretin / zenagamtide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female.
•Age 18-75 years (both inclusive) at the time of signing the informed consent.
•Diagnosed with type 2 diabetes more than or equal to (≥)180 days before screening.
•Only stable daily dose(s) of metformin at effective or maximum tolerated dose, as judged by the investigator for at least 90 days before screening. If additional oral antidiabetic drug (OAD) is required, only stable dose(s) of sodium-glucose cotransporter-2 inhibitors (SGLT2i) is permitted, and this must also have been maintained for at least 90 days before screening.
•HbA1c at screening of 6.5-9.5% [48-80 millimole per mole (mmol/mol)] (both inclusive) if on metformin only, or 6.0-9.0% (42-75 mmol/mol) (both inclusive) if on metformin in combination with SGLT2i.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
•Presence of type 1 diabetes.
•Any clinically significant body weight change (≥5% self-reported change) or dieting attempts (e.g., participation in a weight reduction program) within 90 days before screening.
•Treatment with any medication for the indication of T2D or weight management 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.
•Treatment with a GLP-1 receptor agonist.
•Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) before screening or are expected to require treatment after screening. Diabetic retinopathy or maculopathy must be verified by an eye 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.
•Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders within 180 days before screening.
•Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 60.0 milliliter per minute per meter square (ml/min/1.73 m^2) at screening.

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

12 endpoints
Primary/protocol endpoint

Change in M-value in Hyperinsulinaemic euglycaemic clamp (HEC)

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in M-value in HEC, normalised by lean body mass

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in first-phase incremental Insulin Secretion Rate (ISR0-8 min) in Hyperglycaemic clamp (HGC)

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in second-phase ISR (ISR20-120 min) in HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in total ISR (ISR0-120 min) in HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in ISR at fixed glucose concentration (ISRg) in HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in total insulin response [total area under curve (AUC0-120) min] in HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in clamp disposition index (cDI) calculated from HEC and HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in cDI calculated from HEC and HGC, based on lean body mass

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in β-cell glucose sensitivity (insulin secretion) from HGC

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in β-cell glucose sensitivity from mixed meal tolerance test (MMTT) (slope of dose-response for insulin secretion vs. plasma glucose)

Time frame:Baseline to week 40

change from baseline, improvement

Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c)

Time frame:Baseline to week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.