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

NCT05227196
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Phase
Phase 1
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Recruitment status
Completed
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Participants
546
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Lead sponsor
Novo Nordisk A/S
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Start date
2022-02-04
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Number of sites
3
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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).
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Short title
A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
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Official title
A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1
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Study type
Interventional
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Completion date
2023-08-08
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First posted
2022-02-07
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Registry last updated
2024-09-19
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Primary completion date
2023-06-28
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Start date
2022-02-04
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Actual participants
546
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Participants
546
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
3
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Novo Nordisk A/S
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05227196
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ClinicalTrials.gov ID
NCT05227196
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Registry record
Open registry record
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Allocation
Randomised
Model
Crossover
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)

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

    h∙nmol/L

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

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

    nmol/L

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

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

    h

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

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

    nmol/L

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
Yes

  • 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.

  • 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
Sources for eligibility
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  • Altasciences Clinical LA, Inc.Cypress, United States
  • Altasciences Clinical Kansas, Inc.Overland Park, United States
  • Altasciences Company Inc.Montreal, Canada
Sources for sites
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Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)