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Glucagon-like peptide-1 receptor agonist
Oral Semaglutide Formulations for Healthy Volunteers
Phase 1
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 0 to 24 hours after dosing on days 77, 112 and 147
Awards & highlights
Study Summary
This trial tests different versions of an investigational medicine, semaglutide, in up to 260 participants to measure the amount of semaglutide in the blood. Participants take tablets daily for 18 weeks and are randomized to 1 of 4 groups. No food/water 2 hrs before dose & no other meds 14 days prior. Women can't be pregnant/breastfeeding.
Who is the study for?
This trial is for healthy adults with a BMI between 23.0 and 34.9 who are not pregnant, breastfeeding, or planning pregnancy. They must not have gastrointestinal disorders affecting drug absorption or any condition that could risk their safety or study compliance.Check my eligibility
What is being tested?
The study compares two tablet versions of Semaglutide (J & C), each containing different amounts of SNAC as a helping agent. Participants will be randomly assigned to one of four groups to test various doses over a period of 21 weeks.See study design
What are the potential side effects?
Specific side effects aren't listed, but participants undergo a dose escalation period to minimize potential risks. Common side effects for drugs like semaglutide may include digestive issues, headache, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 0 to 24 hours after dosing on days 77, 112 and 147
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 0 to 24 hours after dosing on days 77, 112 and 147
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC0-24h,semaglutide,SS; area under the semaglutide plasma concentration-time curve during a dosing interval at steady state
Secondary outcome measures
Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state
tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state
Trial Design
4Treatment groups
Experimental Treatment
Group I: Sequence D: Semaglutide J-Semaglutide C-Semaglutide JExperimental Treatment2 Interventions
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 2 once daily for 4 weeks followed by semaglutide C (2x dose) once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks.
Group II: Sequence C: Semglutide J-Semaglutide J-Semaglutide CExperimental Treatment2 Interventions
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide J at dose level 3 once daily for next 4 weeks and thereafter semaglutide C (2x dose) once daily for next 4 weeks.
Group III: Sequence B: Semaglutide C-Semaglutide J-Semaglutide JExperimental Treatment2 Interventions
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide C once daily for 4 weeks followed by semaglutide J at dose level 2 once daily for next 4 weeks and thereafter semaglutide J at dose level 4 once daily for next 4 weeks.
Group IV: Sequence A: Semaglutide J-Semaglutide C-Semaglutide JExperimental Treatment2 Interventions
After 6 weeks of run-in dose escalation period participants will orally receive semaglutide J at dose level 1 once daily for 4 weeks followed by semaglutide C once daily for next 4 weeks and thereafter semaglutide J at dose level 3 once daily for next 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide J
2022
Completed Phase 3
~410
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,414,769 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
139,529 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have serious stomach or intestine problems that affect how I absorb medicine.I am pregnant, breastfeeding, planning to become pregnant, or not using effective birth control.I haven't taken any drugs except for contraceptives, vitamins, topical meds, or occasional pain relievers recently.Your BMI must be between 23.0 and 34.9 kg/m^2, inclusive, at the time of assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Sequence B: Semaglutide C-Semaglutide J-Semaglutide J
- Group 2: Sequence A: Semaglutide J-Semaglutide C-Semaglutide J
- Group 3: Sequence C: Semglutide J-Semaglutide J-Semaglutide C
- Group 4: Sequence D: Semaglutide J-Semaglutide C-Semaglutide J
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age restriction for participation in this experiment above or below 55 years of age?
"The current study stipulates that participants are between 18 and 64 years old. However, there are 54 trials for younger patients and 370 dedicated to seniors."
Answered by AI
What criteria must a person satisfy in order to be accepted into this research?
"To be eligible for this experiment, potential participants must have no underlying health conditions and lie between 18 - 64 years old. In total, there are 260 slots to fill in the trial."
Answered by AI
Is the enrollment period for this trial open at present?
"Clinicaltrials.gov states that this particular medical study is no longer enrolling participants, having opened and closed on March 15th and 13th of 2023 respectively. However, there are still 827 other trials actively seeking volunteers at the moment."
Answered by AI
Has the FDA sanctioned Sequence A: Semaglutide J-Semaglutide C-Semaglutide J?
"Due to it being a Phase 1 trial, with limited data on efficacy and safety, our group at Power rated Sequence A: Semaglutide J-Semaglutide C-Semaglutide J as having a low level of safety (1 out of 3)."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Novo Nordisk Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I am a research coordinator who wants to be a part of a study instead of leading it.
PatientReceived 1 prior treatment
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