GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

152

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-29.9•Healthy volunteers

Primary endpoints

•AUC of semaglutide during a dosing interval•AUC of dapagliflozin during a dosing interval

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 IDNCT05429593

Org study IDNN9917-4751

Secondary ID2022-500007-52-00EU CT number

Secondary IDU1111-1266-4254World Health Organization (WHO)

Timeline

Milestones

Study start2022-06-22actual

Study first posted2022-06-23actual

Primary completion2023-03-10actual

Study completion2023-04-13actual

Last update posted2024-08-07actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female

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

•Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).

•Considered to be generally healthy 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.

Exclusion criteria

•Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation.

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

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

•Use of tobacco and nicotine products, defined as any of the below:

–Smoking more than 5 cigarettes or the equivalent per day

–Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods

•Blood donation, plasma donation or blood draw, defined as any of the below:

–In excess of 400 mL within the past 90 days prior to the day of screening

–In excess of 50 mL within the past 30 days prior to the day of screening

•History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant.

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

Endpoints (6)

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.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state

Time frame:From 0 to 24 hours on day 49 and 84 in Part 1

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state

Time frame:From 0 to 24 hours on day 49 and 98 in Part 2

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)

Time frame:From 0 to 24 hours on day 49 and 84 in Part 1

Cmax

concentration, descriptive

Secondary/protocol endpoint

Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state

Time frame:From 0 to 24 hours on day 49 and 98 in Part 2

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state

Time frame:From 0 to 24 hours on day 49 and 84 in Part 1

Tmax

concentration, descriptive

Secondary/protocol endpoint

tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state

Time frame:From 0 to 24 hours on day 49 and 98 in Part 2

Tmax

concentration, descriptive

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.