Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

A Randomised, Double-blind, Placebo Controlled, Double Dummy, Single-centre Trial in Healthy Subjects Comparing the Steady-state Exposure of Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02557620

Enrollment

113

Registered

2015-09-23

Start date

2015-09-30

Completion date

2016-04-30

Last updated

2017-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

Brief summary

This trial is conducted in Europe. The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

Interventions

DRUGsemaglutide

Administered subcutaneously (s.c., under the skin)once daily or once weekly.

DRUGplacebo

Administered subcutaneously (s.c., under the skin)once daily or once weekly.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent * 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 screeningvisit, as judged by the investigator * Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive) * HbA1c (glycosylated haemoglobin) below 6.5%

Exclusion criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice) * Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol * History of pancreatitis (acute or chronic) * Screening calcitonin equal or above 50 ng/L * Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)

Design outcomes

Primary

Measure	Time frame
Area under the semaglutide concentration-time curves	At steady-state from 0 to168 hours after dosing on day 78

Secondary

Measure	Time frame
Maximum observed semaglutide plasma concentration	At steady-state derived from the concentration-time curves, within 168 hours from day 78
Number of treatment emergent adverse events (TEAEs)	From baseline (day 1, post-dose) to last follow-up visit (day 120)
Area under the the single dose concentration-time curve	From 0 to 300 min after administration of paracetamol (1.5 g) at day 51

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026