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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
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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
2,789 Previous Clinical Trials
8,066,965 Total Patients Enrolled
4 Trials studying Obesity
730 Patients Enrolled for Obesity
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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
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