Clinical trial NCT05227196: A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People
Official title: A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2022-02-07
Enrollment: 546
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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:

* 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

Primary outcomes:
measure: 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.
measure: 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.
Secondary outcomes:
measure: 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.
measure: 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.
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical LA, Inc.
state: California
city: Overland Park
country: United States
facility: Altasciences Clinical Kansas, Inc.
state: Kansas
city: Montreal
country: Canada
facility: Altasciences Company Inc.
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (Dept. 2834)
role: STUDY_DIRECTOR
References: