GLP-1 Peptide Atlas, by Delfa

Active not recruitingPhase 1

A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes

A Study to Investigate Efficacy and Safety of NNC0194-0499 Versus Placebo, Both Administered Alone or in Combination With Semaglutide in People With Type 1 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

NNC0194-0499 / Semaglutide

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criteria

•BMI 22-35•HbA1c 7.2-9%

Primary endpoint

•CGM time-in-range

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 IDNCT07087795

Org study IDNN6497-8316

Secondary ID2024-519533-38European Medical Agency (EMA)

Secondary IDU1111-1315-5122World Health Organization (WHO)

Timeline

Milestones

Study start2025-07-01actual

Study first posted2025-07-28actual

Last update posted2026-04-03actual

Primary completion2026-09-12estimated

Study completion2026-09-25estimated

Assets

Investigational agents

NNC0194-0499 Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female.

•Age 18-64 years (both inclusive) at the time of signing the informed consent.

•Body mass index 22-35 kilogram per square meter (kg/m^2) (both inclusive) for Part A and 27-35(kg/m^2) (both inclusive) for Part B at the day of screening.

•Diagnosed with type 1 diabetes mellitus greater than equal to (≥) 1 year prior to the day of screening.

•Treated with multiple daily insulin injections and stable insulin dose greater than (>) 90 days prior to the day of screening, as judged by the investigator.

•Use of Continuous glucose monitoring (CGM) device > 180 consecutive days prior to the day of screening.

•Glycated haemoglobin (HbA1c) from 7.2 - 9.0% (both inclusive).

•Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

•Ability and willingness to wear the Novo Nordisk provided CGM device according to the protocol including replacement of CGM sensor at home.

•Ability and willingness to refrain from wearing own CGM/Flash glucose monitor for the duration of the study, as judged by the investigator.

Exclusion criteria

•Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

•Treatment with glucagon-like peptide-1(GLP-1) RA within 90 days before screening.

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

•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.

•Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with diabetes mellitus and obesity).

•Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within 180 days prior to the day of screening.

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

Endpoints (13)

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

Glycemic / diabetes

Safety / tolerability / PK

Cardiometabolic biomarkers

Glycemic / diabetes

10 endpoints

Primary/protocol endpoint

Part A: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)

Time frame:From baseline (day -14 - -1) to day 36-49 / day 106-119

CGM time-in-range

change from baseline, improvement

Primary/protocol endpoint

Part B: Change in time in range (TIR) 3.9-10.0 mmol/L (70-80 mg/dL)

Time frame:From baseline (day -14 - -1) to day 92-105 / day 162-175

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Change in coefficient of variation (CV) of sensor glucose, total

Time frame:Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

change from baseline, improvement

Secondary/protocol endpoint

Change in mean sensor glucose (SG)

Time frame:Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

change from baseline, improvement

Secondary/protocol endpoint

Change in time above range (TAR) >10.0 mmol/L (>180 mg/dL)

Time frame:Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Change in time above range (TAR) >13.9 mmol/L (>250 mg/dL)

Time frame:Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

CGM time-above-range

change from baseline, improvement

Secondary/protocol endpoint

Time below range (TBR) <3.9 mmol/L (70 mg/dL)

Time frame:Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Time below range (TBR)<3.0 mmol/L (54 mg/dL)

Time frame:Part A: day 36-49/ day 106-119; Part B: day 92-105/ day 162-175

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Change in time in tight range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL)

Time frame:Part A: From baseline (day -14 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -14 - -1) to day 92-105 / day 162-175

change from baseline, improvement

Secondary/protocol endpoint

Change in mean total daily insulin dose per kg

Time frame:Part A: From baseline (day -3 - -1) to day 36-49 / day 106-119; Part B: From baseline (day -3 - -1) to day 92-105 / day 162-175

ratio, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in triglycerides

Time frame:Part A: From baseline (day 1) to day 50/ day 120; Part B: From baseline (day 1) to day 106/ day 176

Triglycerides, change

ratio, improvement

LOINC 2571-8

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Number of adverse events (AEs)

Time frame:Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of severe hypoglycaemic episodes (level 3)

Time frame:Part A: From baseline (day 1) to day 155; Part B: From baseline (day 1) to day 211

Severe hypoglycemia

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.