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RGT001-075 Group for Obesity

Phase 2
Recruiting
Research Sponsored by Regor Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 weeks
Awards & highlights

Study Summary

This trial is testing a new medication called RGT001-075 to help overweight individuals lose weight. Participants will be randomly assigned to receive either RGT001-075 or a placebo for 12 weeks

Who is the study for?
This trial is for adults aged 18 to 75 with obesity, defined as having a BMI between 27 and 45. Participants should have maintained a stable body weight for the last three months before starting the trial.Check my eligibility
What is being tested?
The study tests RGT001-075 against a placebo to see if it helps with weight loss. Participants will be randomly assigned to receive either RGT001-075 or a dummy pill daily for 12 weeks.See study design
What are the potential side effects?
Potential side effects of RGT001-075 are not specified here, but common weight loss drug side effects may include nausea, constipation, headache, dry mouth, and dizziness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Treatment-emergent Adverse Event(AE) by severity/Serious Adverse Event (SAE), with Clinical Laboratory Abnormalities, Clinically Significant Change From Baseline in Vital Signs and Abnormal Electrocardiogram(ECG) readings
Secondary outcome measures
Change in Body mass index (BMI) in kg/m^2
Change in body weight in kilogram
Change in waist circumference in centimetre
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RGT001-075 GroupExperimental Treatment1 Intervention
Patients will receive once daily dose of study drug for a total of 12 weeks
Group II: Placebo GroupPlacebo Group1 Intervention
Patients will receive once daily dose of matching placebo for a total of 12 weeks

Find a Location

Who is running the clinical trial?

Regor Pharmaceuticals Inc.Lead Sponsor
4 Previous Clinical Trials
131 Total Patients Enrolled

Frequently Asked Questions

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

Is the clinical trial allowing participation of individuals older than 45 years?

"Individuals over 18 years and under the age of 75 are eligible for enrollment in this study."

Answered by AI

Has the RGT001-075 Group received approval from the FDA?

"Based on the phase 2 trial status of RGT001-075 Group, it has been assigned a safety rating of 2 by our team at Power."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"At the moment, patient enrollment is ongoing at 10 different sites. These include Medford, East Greenwich, Valparaiso, and several other undisclosed locations. Opting for the closest site to your residence will reduce travel burdens upon participation in this trial."

Answered by AI

What is the current number of individuals being selected to participate in this clinical investigation?

"Indeed, the information on clinicaltrials.gov shows that this trial is actively seeking volunteers. The initial posting of this medical study was on March 8th, 2024, and its latest update occurred on April 2nd, 2024. A total of 60 participants are being sought across ten different sites."

Answered by AI

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

"According to the details on clinicaltrials.gov, this research is currently in need of participants. The trial was publicly listed on March 8th, 2024 and underwent its most recent revision on April 2nd, 2024."

Answered by AI

Which specific criteria must individuals meet in order to be considered suitable candidates for enrollment in this medical study?

"To be considered for enrollment in this research, individuals aged 18 to 75 with a body mass index (BMI) ranging from 27 kg/m² to 45 kg/m² and maintaining consistent weight levels over the previous three months are eligible."

Answered by AI

Who else is applying?

What site did they apply to?
Velocity Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
~30 spots leftby Jun 2024