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CompletedNCT02557620Updated Jan 4, 2017

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

A Phase 1 interventional study of semaglutide and placebo in Diabetes and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-04.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Healthy
03

In context

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    semaglutide OD + placebo semaglutide OW

    Drug: semaglutide · Drug: placebo

  • Placebo comparator
    placebo semaglutide OW + placebo semaglutide OD

    Drug: placebo

  • Experimental
    semaglutide OW + placebo semaglutide OD

    Drug: semaglutide · Drug: placebo

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.

06

What researchers measure

Primary outcomes

  1. Area under the semaglutide concentration-time curves

    Time frame: At steady-state from 0 to168 hours after dosing on day 78

Secondary outcomes

  1. Maximum observed semaglutide plasma concentration

    Time frame: At steady-state derived from the concentration-time curves, within 168 hours from day 78

  2. Number of treatment emergent adverse events (TEAEs)

    Time frame: From baseline (day 1, post-dose) to last follow-up visit (day 120)

  3. Area under the the single dose concentration-time curve

    Time frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 51

  4. Area under the the single dose concentration-time curve

    Time frame: From 0 to 300 min after administration of paracetamol (1.5 g) at day 79

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Berlin, 10117, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02557620
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 23, 2015
Start date
Sep 2015
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Jan 4, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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