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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 up to 24 weeks
Awards & highlights
Study Summary
This trial studies if a drug can help reduce weight in obese adults.
Who is the study for?
Adults with obesity (BMI ≥ 30 kg/m^2) who have tried and failed at least one diet, have had a stable weight for the last 90 days, and are not pregnant or breastfeeding. Participants must not consume excessive alcohol, use weight-affecting medications or supplements recently, have certain medical conditions like untreated diabetes or inflammatory diseases, nor should they have a history of significant mental health issues.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new medication called S-309309 in reducing body weight compared to a placebo. Obese adults will be randomly assigned to receive either the study drug or an inactive substance to see if there's any difference in their weight loss outcomes.See study design
What are the potential side effects?
While specific side effects for S-309309 aren't listed here, common side effects from weight loss drugs can include digestive issues like nausea and constipation, headaches, dizziness, dry mouth, and potential changes in mood or sleep patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
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 Body Weight
Secondary outcome measures
Change From Baseline in Adiponectin
Change From Baseline in BMI
Change From Baseline in Body Composition: Lean Mass as Assessed by DEXA scan
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Dose Level 3: S-309309Experimental Treatment1 Intervention
Participants will receive S-309309 (high dose) once daily for 24 weeks
Group II: Dose Level 2: S-309309Experimental Treatment1 Intervention
Participants will receive S-309309 (middle dose) once daily for 24 weeks
Group III: Dose Level 1: S-309309Experimental Treatment1 Intervention
Participants will receive S-309309 (low dose) once daily for 24 weeks
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive placebo once daily for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S-309309
2022
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
ShionogiLead Sponsor
116 Previous Clinical Trials
41,121 Total Patients Enrolled
6 Trials studying Obesity
2,906 Patients Enrolled for Obesity
Medical DirectorStudy DirectorShionogi
2,777 Previous Clinical Trials
8,064,039 Total Patients Enrolled
4 Trials studying Obesity
730 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.I have lost or gained more than 11 pounds in the last 3 months.I haven't taken drugs affecting P-gp in the last 28 days.I am a female and my pregnancy test was positive during screening.I am currently breastfeeding.My BMI is 30 or higher, indicating obesity.I have not had cancer, except for non-dangerous skin or treated cervical cancer, in the last 5 years.My obesity is caused by an untreated hormone condition.I have a blood disorder affecting my hemoglobin or chronic anemia.I have a history of diabetes, treated or untreated.I haven't had severe mental health issues or taken related meds in the last 2 years.I do not have major health issues that could affect how my body handles medication.I do not have liver disease, except for fatty liver, NASH, Gilbert's syndrome, or gallstones.My kidney function is reduced, with an eGFR below 60.I have used steroids for more than 15 days in the last 6 months, except for skin treatments.I haven't taken any medications that can change my weight in the last 3 months.I am not taking any supplements for weight management.I have a family history or signs of genetic obesity.I have a history of inflammatory or autoimmune conditions.I cannot swallow pills.I haven't had COVID-19 or been in close contact with someone who has, in the last 14 days.I have had or plan to have weight loss surgery or an intra-abdominal balloon.My heart's electrical cycle length is within safe limits.I have a lens opacity or cataract affecting my vision.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Level 3: S-309309
- Group 2: Dose Level 1: S-309309
- Group 3: Dose Level 2: S-309309
- Group 4: Placebo
Awards:
This trial has 0 awards, including: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.
Obesity Patient Testimony for trial: Trial Name: NCT05925114 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have registered for this experiment?
"Absolutely. Clinicaltrials.gov has the latest information on this medical trial, which was established on June 21st 2023 and amended recently on June 30th 2023. A total of 320 participants are required to be recruited from 3 different sites."
Answered by AI
Has the FDA sanctioned Dose Level 1: S-309309?
"Through rigorous analysis, our team at Power has assigned Dose Level 1: S-309309 a score of 2 on the safety scale; this is because Phase 2 trials suggest that there are some preliminary data suggesting its security, yet no efficacy study results."
Answered by AI
Are recruitment efforts still ongoing for this clinical experiment?
"This clinical trial is currently recruiting participants, according to the information available on clinicialtrials.gov. It was first made known to the public on June 21st 2023 and underwent its most recent edit on June 30th of the same year."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Alabama
Texas
Other
What site did they apply to?
Foothills Research Center - CCT - PPDS
Lynn Institute of East Oklahoma - ERN PPDS
Palm Research Center, Inc
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0
Why did patients apply to this trial?
To lost 20- 30! Weight lose needed. Tried drugs in past and fail. I never tried medication for obesity.
PatientReceived 2+ prior treatments
Ozempic, weight watchers, atkins, keto.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How many weeks is the trial? How long do the appointments last? Will every person especially me get the real drug and not a placebo drug?? How much would I be paid since I would be traveling from central Virginia?
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Hatboro Medical Associates PC: < 48 hours
Average response time
- < 2 Days
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