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Glucagon-like peptide-1 receptor agonist

Semaglutide J for Type 2 Diabetes

Phase 3
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 baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
Awards & highlights

Study Summary

This trial is testing a new way to make the diabetes drug semaglutide, to see if it controls blood sugar better than the current version.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline visit (visit 2; week 0) to end of study visit (visit 11; week 33) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Secondary outcome measures
Antibodies
Anti-semaglutide Antibodies Level Measured as %Bound/Total
Change in Body Weight
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Semaglutide JExperimental Treatment1 Intervention
Participants will initially receive 0.25 milligrams (mg) subcutaneous injections of semaglutide J once weekly (OW) and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
Group II: Semaglutide BActive Control1 Intervention
Participants will initially receive 0.25 mg subcutaneous injections of semaglutide B OW and the dose will be then escalated once in 4 weeks for 8 weeks until the target maintenance dose of 1.0 mg is reached which will be maintained for a period of 20 weeks. Metformin will be considered as background therapy during the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide J
2022
Completed Phase 3
~410

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,664 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
106 Previous Clinical Trials
139,424 Total Patients Enrolled

Media Library

Semaglutide B (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05478252 — Phase 3
Type 2 Diabetes Research Study Groups: Semaglutide B, Semaglutide J
Type 2 Diabetes Clinical Trial 2023: Semaglutide B Highlights & Side Effects. Trial Name: NCT05478252 — Phase 3
Semaglutide B (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05478252 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05478252 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people currently signing up for this experiment?

"This trial, which was originally advertised on August 3rd, is still looking for patients according to the listing on clinicaltrials.gov. The most recent update to the posting was made on November 10th."

Answered by AI

In how many different countries is this medical study being conducted?

"Right now, the trial is taking place in 46 different locations. A few of these places are Atlanta, Savannah and Blackfoot. To lower the demand for travel if you enroll, try to pick a location near you."

Answered by AI

How many people are willing to participate in this experiment?

"That is correct. The most recent update on clinicaltrials.gov reveals that this study, which was originally posted on 8/3/2022, is still looking for patients. In total, they are hoping to find 332 individuals across 46 different sites."

Answered by AI

Could I possibly join this clinical trial?

"This research is looking for 332 participants that have type 2 diabetes mellitus and are aged between 18-64."

Answered by AI

What is the FDA's opinion on Semaglutide J?

"Semaglutide J's safety is estimated to be a 3. This evaluation comes from the fact that Semaglutide J is in Phase 3 of clinical trials, which suggests that not only does some data support its efficacy, but multiple rounds of tests also support its safety."

Answered by AI

Does this research include elderly individuals as test subjects?

"For this particular study, only patients aged 18-64 are eligible to apply. Out of the 3113 active clinical trials, 199 are for minors and 1122 are for senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
New York
Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Novo Nordisk Investigational Site
Other
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

Want to help my sugars. looking for something other than daily Metformin. I'm already taking semaglutide and you would be shocked at my results already.
PatientReceived no prior treatments
I've tried other drugs that don't have the desired effect or outcome, and I want to take a different approach.
PatientReceived no prior treatments
Diabetic type 2, overweight since using insulin. Would like to help research to find solutions to problems many face.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is the trial for? Does our insurance have to pay for this? Is there any cost to me? Once the trials are over will we not be able to use the medication anymore?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
~150 spots leftby Apr 2025