GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 3

A Research Study to See if Two Different Formulations of Oral Semaglutide Are Equally Safe and Effective in Reducing the Blood Sugar Level in Japanese People With Type 2 Diabetes

A Study Investigating Clinical Comparability of Two Formulations of Oral Semaglutide in Japanese Participants With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

264

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10.5%

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 IDNCT07271251

Org study IDNN9924-8485

Secondary IDU1111-1321-8272World Health Organization (WHO)

Timeline

Milestones

Study start2025-12-01actual

Study first posted2025-12-09actual

Last update posted2026-03-31actual

Primary completion2026-06-29estimated

Study completion2026-08-03estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

•Japanese male or female.

•Age 18 years or above at the time of signing the informed consent.

•Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 90 days prior to day of screening.

•Glycated haemoglobin (HbA1c) of 7.0-10.5 percent (%) (53-91 millimoles per mole [mmol /mol]) (both inclusive) at screening.

•Stable daily dose(s) ≥ 60 days before screening with any 1-2 of the following oral antidiabetic drugs (OADs): Sulfonylurea (SU), glinide, thiazolidinedione (TZD), alpha-glucosidase inhibitor (α-GI), sodium-glucose cotransporter 2 (SGLT-2) inhibitor or metformin (effective or maximum tolerated dose as judged by the investigator) according to Japanese labelling.

Exclusion criteria

•Known or suspected hypersensitivity to study intervention(s) or related products.

•Previous participation in this study. Participation is defined as signed informed consent.

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.

•Current participation (i.e., signed informed consent) in any other interventional clinical study.

•Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.

•Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.

•Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.

•Anticipated initiation or change in concomitant medications for more than 14 consecutive days affecting weight or glucose metabolism.

•Use of any medication with unknown or unspecified content within 90 days before screening.

•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

•Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

•History or presence of pancreatitis (acute or chronic).

•History of major surgical procedures involving the stomach potentially affecting absorption of study products or current presence of gastrointestinal implant.

•Myocardial infarction, stroke, transient ischaemic attack or hospitalization for unstable angina pectoris within 60 days before screening.

•Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.

•Planned coronary, carotid or peripheral artery revascularisation.

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified within 90 days before screening or in the period between screening and randomisation.

•Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥ 2.5 times or Bilirubin >1.5 times upper normal limit at screening.

•Renal impairment with estimated glomerular filtration rate (eGFR) less than (<) 30 millilitres per minute per meter square (mL/min/1.73 m^2) as per 2021 Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) formula (by creatinine) at screening.

•Treatment with medication for 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.

•Presence or history of malignant neoplasms or in situ carcinomas within 5 years before screening.

•Any episodes of diabetic ketoacidosis within 90 days before screening.

Endpoints (3)

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

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to end of treatment (week 20)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Change in glycated haemoglobin (HbA1c).

Time frame:From baseline (week 0) to end of treatment (week 20)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 25)

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.