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

NCT ID: NCT06517797

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-12-15

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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

Group Type: EXPERIMENTAL

S1B-509 low dose

Intervention Type: DRUG

S1B-509 has multiple neurotransmitter activities

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matched pills to S1B-509

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

twice the dose of "S1B-509 low dose"

Group Type: EXPERIMENTAL

S1B-509 High Dose

Intervention Type: DRUG

S1B-509 has multiple neurotransmitter activities

Interventions

S1B-509 low dose

S1B-509 has multiple neurotransmitter activities

Intervention Type: DRUG

Placebo

matched pills to S1B-509

Intervention Type: DRUG

S1B-509 High Dose

S1B-509 has multiple neurotransmitter activities

Intervention Type: DRUG

Other Intervention Names

proprietary combination of trazodone and bupropion at low dose; proprietary combination of trazodone and bupropion at high dose

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. 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.

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

3. Bariatric surgery

4. 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

5. History of ketoacidosis, lactic acidosis, or hyperosmolar coma, or any of these occurring between Visit 1 and 2/randomization

6. Diabetics with HbA1c levels over 10 percent or fasting glucose levels greater than or equal to 270 mg/dl.

7. Symptomatic infection in the 4 weeks prior to screening or randomization.

8. Gastro-intestinal (GI) disorders associated with chronic diarrhea.

9. Congestive heart failure, New York Heart Association (NYHA) class III or IV

10. Body dysmorphic disorder or compulsive eating disorder

11. 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.

12. Requires CYP3A4, CYP 2B6, or CYP 2D6 strong inhibitor or inducer drugs

13. Takes any sex hormone other than an approved hormonal contraceptive

14. Takes an antiepileptic/mood stabilizer, antipsychotic, antidepressant, anxiolytic, or hypnotic drug

15. Drinks more than 7 alcoholic drinks per week (12-oz beer, 4-oz wine, 1 ½ oz liquor etc)

16. Uses marijuana more than once a week

17. History of seizures as an adult or use of antiepileptic medication

18. Long QT syndrome (QTc <=480 msec), other significant cardiovascular disease (hypertension controlled with one medication is acceptable)

19. Moderate or severe dysfunction of the liver (any LFT >=3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0)

20. Uses sedating antihistamines or prescription sedatives daily

21. History of blood clots or abnormal bleeding tendencies, including daily use of medications adversely affecting coagulation, e.g., NSAIDs, systemic corticosteroids, or >81 mg aspirin daily.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S1 Biopharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas E Sitchon, B.S.

Role: STUDY_CHAIR

S1 Biopharma, Inc.

Central Contacts

Anita Clayton, MD

Role: CONTACT

AHC8V@hscmail.mcc.virginia

4342434649

Robert E Pyke, MD,PhD

Role: CONTACT

robertepyke@gmail.com

2033992390

Other Identifiers

S1B-509-2000

Identifier Type: -

Identifier Source: org_study_id