NCT06517797

One-Year Study of S1B-509 vs Placebo for Weight Loss

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: S1 Biopharma, Inc. · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study to test whether S1B-509 given orally daily helps people with overweight or obesity to lose more weight than with placebo over a year.

Detailed description

This trial is to determine proof of concept for S1B-509 vs. placebo and to define a suitable dose escalation scheme and range for S1B-509 regarding safety, tolerability, and efficacy. The treatments will be given along with dietary advice and food intake monitoring. Change in body weight and in measures relating to obesity and its complications such as diabetes will be measured from baseline to week 48. Safety will be determined from adverse event reports, vital signs, routine laboratory tests, and mental health screeners.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	S1B-509 low dose	S1B-509 has multiple neurotransmitter activities
DRUG	Placebo	matched pills to S1B-509
DRUG	S1B-509 High Dose	S1B-509 has multiple neurotransmitter activities

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-06-15
• Completion: 2027-12-15
• First posted: 2024-07-24
• Last updated: 2025-06-18

Regulatory

• FDA-regulated drug study