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S1B-509 for Weight Loss and Obesity-Related Complications

Study Aim

This study will evaluate the effectiveness of S1B-509 in helping adults lose weight and reduce obesity-related complications.

What is being tested

S1B-509 low dose

+ Placebo

+ S1B-509 High Dose

Drug

Who is being recruted

Body Weight+9

+ Diabetes Mellitus

+ Endocrine System Diseases

From 25 to 70 Years

+30 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: October 2025

See protocol details

Summary

Principal SponsorS1 Biopharma, Inc.

Study ContactAnita Clayton, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial is exploring a new treatment, S1B-509, to help people lose weight. The study focuses on individuals who are struggling with obesity, a condition that can lead to serious health problems like diabetes. Researchers are testing if S1B-509 can effectively help reduce weight compared to a placebo, which is a substance with no active medication. This study is important because finding a safe and effective weight-loss treatment could significantly improve the health and quality of life for many people dealing with obesity. Participants in the study receive either the new medication, S1B-509, or a placebo, alongside dietary advice and monitoring of their food intake. The medication's effectiveness is assessed by measuring changes in body weight and other obesity-related health markers over 48 weeks. Safety is closely monitored through reports of any side effects, checking vital signs, conducting routine lab tests, and mental health evaluations. This approach helps ensure that any potential risks are minimized and that the benefits of the treatment are thoroughly evaluated.

Official TitlePhase IIb Placebo-Controlled Double-Blind Randomized Parallel Groups Study to Determine the Efficacy and Safety of S1B-509 for Weight Loss

NCT06517797

Principal SponsorS1 Biopharma, Inc.

Study ContactAnita Clayton, MDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

210 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutrition DisordersNutritional and Metabolic DiseasesObesitySigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionGlucose Metabolism DisordersOverweight

Criteria

9 inclusion criteria required to participate

Patients with obesity disease and inadequately controlled body weight with diet and/or exercise

Body mass index (BMI) ≥ 27 kg/m2 with significant comorbidity, e.g., type 2 diabetes, hypertension, dyslipidemia, sleep apnea, cardiovascular disease

Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female

Visceral fat area ≥ 100 cm2

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21 exclusion criteria prevent from participating

Use of pharmacologically active weight-loss medications, glucagon-like peptide-1 (GLP-1) agonists or sodium-glucose co-transporter 2 (SGLT2) inhibitors, within 3 months of screening, or between screening and randomization.

Use of alpha glucosidase inhibitors within 3 months of Visit 1, or between screening and randomization.

Bariatric surgery

Lack of compliance with lifestyle intervention (defined as weight gain during 4-week Screening/run-in or with study medication (defined as < 80% study drug intake in more than one 4-week period

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Simultaneous oral dosing once daily with two to four extended-release tablets or capsules of S1B-509, for 48 weeks

Group II

Placebo

Simultaneous oral dosing once daily with two to four placebos, for 48 weeks

Group III

Experimental

twice the dose of "S1B-509 low dose"

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

Recruiting soonNo study centers