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

NCT06517797 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: S1B-509-2000
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Keywords

S1B-509; diabetes

Outcome Measures

Primary Outcomes (2)

• Per cent weight change

  100 (Weight at follow-up) - (weight at baseline)/(weight at baseline)

  48 weeks

• Proportion losing at least 5% body weight

  (number of subjects (no. ss) per group losing at least 5% body weight)/(total no. ss/group

  48 weeks

Secondary Outcomes (12)

• Waist circumference

  48 weeks

• Proportion losing 10%

  48 weeks

• Proportion losing 15%

  48 weeks

• Change in systolic blood pressure

  48 weeks

• Change in diastolic blood pressure

  48 weeks

Study Arms (3)

S1B-509 (proprietary combination of trazodone and bupropion) low dose

EXPERIMENTAL

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

Drug: S1B-509 low dose

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

S1B-509 (proprietary combination of trazodone and bupropion) high dose

EXPERIMENTAL

twice the dose of "S1B-509 low dose"

Drug: S1B-509 High Dose

Interventions

S1B-509 low dose DRUG

S1B-509 has multiple neurotransmitter activities

Also known as: proprietary combination of trazodone and bupropion at low dose

S1B-509 (proprietary combination of trazodone and bupropion) low dose

Placebo DRUG

matched pills to S1B-509

Placebo

S1B-509 High Dose DRUG

S1B-509 has multiple neurotransmitter activities

Also known as: proprietary combination of trazodone and bupropion at high dose

S1B-509 (proprietary combination of trazodone and bupropion) high dose

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Agreement to comply with the study-required life-style intervention and treatment during the full duration of the study.
• Side effects from any continuing concomitant medications must be mild and stable or nil.
• Females: not pregnant or lactating for six months; using medically reliable contraception, i.e., diaphragm or (male or female) condom and spermicide, IUD, tubal sterilization, hormonal contraception (oral, vaginal, or implant), or (if the investigator finds the patient credibly monogamous) vasectomy of male partner.
• Gives informed consent for and is willing to undergo all of the scheduled evaluations.
• Prompt for screening and baseline visits, is cooperative, and takes reasonable directions without excessive explanations.

You may not qualify if:

• 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
• History of ketoacidosis, lactic acidosis, or hyperosmolar coma, or any of these occurring between Visit 1 and 2/randomization
• Diabetics with HbA1c levels over 10 percent or fasting glucose levels greater than or equal to 270 mg/dl.
• Symptomatic infection in the 4 weeks prior to screening or randomization.
• Gastro-intestinal (GI) disorders associated with chronic diarrhea.
• Congestive heart failure, New York Heart Association (NYHA) class III or IV
• Body dysmorphic disorder or compulsive eating disorder
• Chronic conditions that may in the investigator's judgment be expected to be unstable and affect overall health are not allowed. Examples: gastrointestinal bleeding in prior 6 months, diabetes mellitus with HB A1C \>8.9, asthma not well controlled with treatment once or twice daily, current Major Depressive Disorder or recurrence of MDD off treatment for at least 2 months, anxiety disorder severe enough to prevent employment, severe sleep apnea, history within the prior year of suicidality or drug abuse, history of active breast, cervical, uterine, ovarian or other systemic cancer within the prior 24 months.
• Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs
• Takes any sex hormone other than an approved hormonal contraceptive
• Takes an antiepileptic/mood stabilizer, antipsychotic, antidepressant, anxiolytic, or hypnotic drug
• Drinks more than 7 alcoholic drinks per week (12-oz beer, 4-oz wine, 1 ½ oz liquor etc)

Sponsors & Collaborators

• S1 Biopharma, Inc.: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nicolas E Sitchon, B.S.

  S1 Biopharma, Inc.

  STUDY CHAIR

Central Study Contacts

Anita Clayton, MD

CONTACT

4342434649; AHC8V@hscmail.mcc.virginia

Robert E Pyke, MD,PhD

CONTACT

2033992390; robertepyke@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: tablets of one of the actives and capsules of the other active matched to placebo tablets and capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment to putatively active treatment at low and high dose or placebo

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 24, 2024
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share