GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

A Research Study to Compare Two Semaglutide Medicines in People With Type 2 Diabetes

Investigation of Clinical Comparability of Semaglutide Drug Products Based on the Proposed and the Approved Drug Substance Manufacturing Processes in Participants With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

104

Recruiting sites

—

Enrollment

388

actual

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 IDNCT05478252

Org study IDNN9535-4820

Secondary ID2021-001501-69

Secondary IDU1111-1266-2391World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-07-28actual

Study start2022-08-03actual

Primary completion2023-08-09actual

Study completion2023-09-18actual

Results first posted2024-10-09actual

Last update posted2025-12-12actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes (T2D) mellitus greater than equal to (≥) 180 days before screening.

•Stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose.

•HbA1c of 7.0-10.5 percentage (%) [53-91.3 millimoles per mole (mmol/mol)] (both inclusive).

Exclusion criteria

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

•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 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 nondilated examination.

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

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 28)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide J	-5.0	—
Semaglutide B	-4.6	—

Secondary/protocol endpoint

Change in Body Weight

Time frame:From baseline (week 0) to end of treatment (week 28)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 28)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of glycosylated haemoglobin	95% CI
Semaglutide J	-1.7	—
Semaglutide B	-1.6	—

Treatment difference-0.1195% CI-0.30 – 0.08p<.0001ANCOVA

Primary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:From baseline (week 0) to end of treatment (week 28)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Number of Treatment-Emergent Adverse Events (TEAEs)

Time frame:From the time of first dosing (week 0) to end of study (week 33)

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide J	156	—
Semaglutide B	52	—

Secondary/registry result

Occurrence of Anti-semaglutide Antibodies (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide J	1	—
	281	—
Semaglutide B	0	—
	90	—

Secondary/registry result

Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Secondary/registry result

Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide JYes	0	—
No	1	—
Semaglutide BYes	0	—
No	0	—

Secondary/registry result

Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)

Time frame:At week 33

Immunogenicity (ADA)

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide JYes	0	—
No	1	—
Semaglutide BYes	0	—
No	0	—

Secondary/registry result

Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total

Time frame:At week 33

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), Percentage of Antisemaglutide Antibodies	95% CI
Semaglutide J	3.47	—

Secondary/registry result

Anti-semaglutide Antibodies Level (Measured as Titre)

Time frame:At week 33

Immunogenicity (ADA)

concentration, descriptive

Posted result

Group	Value (mean), Titre	95% CI
Semaglutide J	15.00	—

Secondary/protocol endpoint

Number of Treatment-Emergent Adverse Events (TEAEs)

Time frame:From the time of first dosing (week 0) to end of study (week 33)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Antibodies (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Antibodies With In-vitro Neutralising Effect (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of Anti-semaglutide Binding Antibodies Cross-reacting With Endogenous Glucagon Like Peptide-1 (GLP-1) (Yes/no)

Time frame:From baseline (week 0) to end of study (week 33)

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Occurrence of In-vitro Neutralising Cross-reacting Antibodies to Endogenous GLP-1 (Yes/no)

Time frame:At week 33

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Antibodies Level Measured as Percentage (%) Bound/Total

Time frame:At week 33

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Anti-semaglutide Antibodies Level (Measured as Titre)

Time frame:At week 33

Immunogenicity (ADA)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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.