GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2

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

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

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Oral · GLP-1 / amylin

Listed sites

119

Recruiting sites

—

Enrollment

448

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤50•HbA1c 7-10%

Primary endpoint

•HbA1c, change

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 IDNCT06542874

Org study IDNN9490-7678

Secondary ID2023-509412-28European Medical Agency (EMA)

Secondary IDU1111-1296-9708World Health Organization (WHO)

Timeline

Milestones

Study first posted2024-08-07actual

Study start2024-08-07actual

Primary completion2025-10-01actual

Study completion2025-10-24actual

Last update posted2025-12-29actual

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, 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.

Endpoints (18)

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.

Coverage by outcome category

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Renal / kidney

Safety / tolerability / PK

Weight & body composition

4 endpoints

Secondary/protocol endpoint

Relative change in body weight

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

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

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

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

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

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

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

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in HbA1c

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

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

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

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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)

CGM time-in-range

change from baseline, improvement

Renal / kidney

3 endpoints

Secondary/protocol endpoint

Change in Urinary Albumin/Creatinine Ratio (UACR)

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

uACR, change

ratio, improvement

LOINC 9318-7

Secondary/protocol endpoint

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)

categorical status, improvement

LOINC 9318-7

Secondary/protocol endpoint

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

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

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change in systolic blood pressure (SBP)

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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

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

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in high sensitivity C-Reactive Protein (hsCRP)

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

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in total cholesterol

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

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in high-density lipoprotein (HDL) cholesterol

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

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in low-density lipoprotein (LDL) cholesterol

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

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in triglycerides

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

Triglycerides, change

ratio, improvement

LOINC 2571-8

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of adverse events

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

Treatment-emergent AEs (any)

event count, event

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.