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GLY-200 for Obesity

Verified Trial
Phase 2
Waitlist Available
Research Sponsored by Glyscend, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 18 to 70 years at the time of screening
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 2, week 4, week 6, week 8, week 12, and week 16
Awards & highlights

Study Summary

This trial will test how well GLY-200 works, how safe it is, and how well participants can tolerate it in people with obesity.

Who is the study for?
This trial is for individuals with obesity who are looking to participate in a study evaluating the effectiveness of a new treatment. Specific eligibility details aren't provided, but typically participants should be adults meeting certain body weight criteria without significant health issues that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing GLY-200, which is potentially a new medication for obesity. Participants will either receive GLY-200 or a placebo (a substance with no therapeutic effect) over 16 weeks to compare outcomes.See study design
What are the potential side effects?
While specific side effects are not listed, common side effects in obesity medication trials can include gastrointestinal issues like nausea or constipation, headaches, increased blood pressure, and potential metabolic changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 2, week 4, week 6, week 8, week 12, and week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 2, week 4, week 6, week 8, week 12, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent change from baseline in weight
Proportion of participants who achieve ≥ 5% body weight reduction
Secondary outcome measures
Change and percent change from baseline in weight
Change from baseline in waist circumference
Incidence of adverse events (AEs) and serious adverse events (SAEs) considered by the Investigator to be related to study drug administration
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GLY-200Experimental Treatment1 Intervention
Participants will receive 2.0 g GLY-200 orally twice daily for 16 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo (identical in appearance to GLY-200) orally twice daily for 16 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLY-200
2022
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Glyscend, Inc.Lead Sponsor
1 Previous Clinical Trials
52 Total Patients Enrolled
Mark Fineman, PhDStudy ChairGlyscend, Inc.
1 Previous Clinical Trials
52 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to enroll in this clinical trial?

"Individuals with obesity aged between 18 and 70 are eligible for participation in this clinical trial, which aims to enroll a total of 70 participants."

Answered by AI

In how many medical institutions is this clinical examination currently being conducted?

"Patients are being enrolled at Sensible Healthcare, LLC in Ocoee, Florida, Clinical Trials of Texas, Inc. in San Antonio, Texas, and Tampa Bay Medical Research, Inc. in Clearwater, Louisiana among an additional 5 undisclosed sites."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"As per clinicaltrials.gov, recruitment for this investigation is currently closed. The trial was first listed on 3/1/2024 and last updated on 2/7/2024. While this particular study is not actively enrolling participants, there are approximately 970 other ongoing trials seeking eligible individuals."

Answered by AI

Are individuals above the age of 70 being considered for participation in this trial?

"Patients aged between 18 and 70 are eligible to participate in this clinical trial. There are a total of 177 trials catering to individuals under the age of 18, while there are 616 studies targeting participants over the age of 65."

Answered by AI

Has the FDA granted approval for GLY-200?

"The safety evaluation of GLY-200 by our team at Power is rated as 2 on a scale from 1 to 3. This rating reflects the ongoing Phase 2 trial, where there is existing data supporting its safety profile but none yet demonstrating efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Tampa Bay Medical Research, Inc.
Tandem Clinical Research, Marrero
Sensible Healthcare, LLC
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Tandem Clinical Research, Marrero: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity
2024. "A 16-Week Study to Evaluate the Efficacy, Safety, and Tolerability of GLY-200 in Participants With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06259981.
All > New Orleans
~47 spots leftby Dec 2024
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