DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

A Multiple-dose, Single-centre, Randomised, Double-blind, Placebo-controlled Trial to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Chinese Subjects

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

32

actual

Study population

Healthy volunteers

Key I/E criteria

•BMI 20-24.9•Healthy volunteers

Primary endpoint

•AUC0-24h,sema,SS, AUC of semaglutide during a dosing interval (0-24 hours)

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 IDNCT04016974
Org study IDNN9924-4303
Secondary IDU1111-1186-6753World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-07-12actual
Study start2019-10-08actual
Primary completion2021-01-23actual
Study completion2021-02-26actual
Last update posted2024-07-12actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
•Body weight equal to or above 54.0 kg
•Body mass index (BMI) between 20.0 and 24.9 kg/m^2 (both inclusive)
•Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
•History of pancreatitis (acute or chronic) as declared by the subject.
•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the subject.
•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject.
•Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).
•Unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator.
•Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding 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

Safety / tolerability / PK
11
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight from baseline

Time frame:Day 1, day 85

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in fasting plasma glucose from baseline

Time frame:Day 1, day 85

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

11 endpoints
Primary/protocol endpoint

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

Time frame:After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84

Cmax

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84

Tmax

descriptive

Secondary/protocol endpoint

CL/Fsema,SS, total apparent clearance of semaglutide at steady state

Time frame:After the last dose of oral semaglutide at dose levels of 3 mg on day 28 and 7 mg on day 56, and after the last 3 daily doses of oral semaglutide at dose level 14 mg on day 82, 83 and 84

concentration, descriptive

Secondary/protocol endpoint

Ctrough,sema,SS, trough semaglutide plasma concentration at steady state

Time frame:After the last 3 daily doses of oral semaglutide administration at 3, 7 and 14 mg dose levels on day 27-29, 55-57 and 83-85

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

t½,sema,SS, terminal half-life of semaglutide at steady state

Time frame:After the last dose of oral semaglutide 14 mg on day 84

Half-life

descriptive

Secondary/protocol endpoint

Vss/Fsema, apparent volume of distribution of semaglutide at steady state

Time frame:After the last dose of oral semaglutide 14 mg on day 84

descriptive

Secondary/protocol endpoint

MRTsema,SS, mean residence time of semaglutide at steady state

Time frame:After the last dose of oral semaglutide 14 mg on day 84

descriptive

Secondary/protocol endpoint

Rtheor,sema,SS, theoretical accumulation index, which is defined as [1/(1-Exp (-λZ,sema,SS*24h))], where λZ,sema,SS=log(2)/t½,sema,SS

Time frame:After the last dose of oral semaglutide 14 mg on day 84

descriptive

Secondary/protocol endpoint

Number of treatment-emergent adverse events

Time frame:From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent hypoglycaemic episodes

Time frame:From the time of first dosing (day 1) until completion of the follow-up visit (day 119-121)

Documented hypoglycemia

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.