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CompletedNCT05227196Updated Sep 19, 2024

A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

A Phase 1 interventional study of Semaglutide D Dose 1 and Semaglutide D Dose 2 in Healthy Volunteers and Type 2 Diabetes, sponsored by Novo Nordisk A/S. Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

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

From the registry’s dates

  • Primary completion was Jun 2023, 3 years 3 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
546
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).

02

Conditions studied

  • Healthy Volunteers
  • Type 2 Diabetes
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 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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

Exclusion Criteria:

  • HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.
  • 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 within 48 hours prior to and during the inpatient periods
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
  • History(a) 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(a).

  • Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).

    1. As declared by the participant or reported in the medical records
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
546 participants (actual)

Study arms

  • Experimental
    Group 1 Sequence 1

    Crossover arm

    Drug: Semaglutide D Dose 1 · Drug: Semaglutide D Dose 2 · Drug: Semaglutide D Dose 3 · Drug: Semaglutide Dose 6

  • Experimental
    Group 1 Sequence 2

    Crossover arm

    Drug: Semaglutide D Dose 3 · Drug: Semaglutide Dose 4 · Drug: Semaglutide Dose 5 · Drug: Semaglutide Dose 6

  • Experimental
    Group 2 Sequence 1

    Crossover arm

    Drug: Semaglutide D Dose 1 · Drug: Semaglutide D Dose 2 · Drug: Semaglutide Dose 4 · Drug: Semaglutide Dose 5

  • Experimental
    Group 2 Sequence 2

    Crossover arm

    Drug: Semaglutide D Dose 1 · Drug: Semaglutide D Dose 2 · Drug: Semaglutide Dose 4 · Drug: Semaglutide Dose 5

  • Experimental
    Group 3 Sequence 1

    Crossover arm

    Drug: Semaglutide D Dose 1 · Drug: Semaglutide Dose 4

  • Experimental
    Group 3 Sequence 2

    Crossover arm

    Drug: Semaglutide D Dose 1 · Drug: Semaglutide Dose 4

Interventions

  • DrugSemaglutide D Dose 1

    Tablet given orally

  • DrugSemaglutide D Dose 2

    Tablet given orally

  • DrugSemaglutide D Dose 3

    Tablet given orally

  • DrugSemaglutide Dose 4

    Tablet given orally

  • DrugSemaglutide Dose 5

    Tablet given orally

  • DrugSemaglutide Dose 6

    Tablet given orally

06

What researchers measure

Primary outcomes

  1. AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)

    h∙nmol/L

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

  2. Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state

    nmol/L

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

Secondary outcomes

  1. tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state

    h

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

  2. Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state

    nmol/L

    Time frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.

07

Study locations

3 sites
  • Altasciences Clinical LA, Inc.
    Cypress, California 90630, United States
  • Altasciences Clinical Kansas, Inc.
    Overland Park, Kansas 66212, United States
  • Altasciences Company Inc.
    Montreal, Quebec H3P 3P1, Canada
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05227196
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 7, 2022
Start date
Feb 4, 2022
Primary completion
Jun 28, 2023
Completion
Aug 8, 2023
Last update
Sep 19, 2024

Study contacts

Clinical Transparency (Dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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