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ObesityPhase 2NCT06517797

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

A Phase 2 study testing S1B-509 low dose and S1B-509 High Dose in people with Obesity, run by S1 Biopharma, Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 25 to 70 years
Conditions the study is for
Obesity
What is being tested?
S1B-509 low dose and S1B-509 High Dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
No sites listed yet
Study dates
15 Oct 2025to 15 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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)
  • Uses marijuana more than once a week
  • History of seizures as an adult or use of antiepileptic medication
  • Long QT syndrome (QTc <=480 msec), other significant cardiovascular disease (hypertension controlled with one medication is acceptable)
  • Moderate or severe dysfunction of the liver (any LFT >=3x ULN) or renal dysfunction (BUN > 30 or Cr >2.0)
  • Uses sedating antihistamines or prescription sedatives daily
  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anita Clayton, MD contact

4342434649

AHC8V@hscmail.mcc.virginia

Robert E Pyke, MD,PhD contact

2033992390

robertepyke@gmail.com

About this study

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

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.

Read the 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
Being tested
S1B-509 low dose, Placebo, S1B-509 High Dose
Keywords
S1B-509; diabetes
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • S1B-509 low doseDrug

    Also called proprietary combination of trazodone and bupropion at low dose

    S1B-509 has multiple neurotransmitter activities

  • PlaceboDrug

    matched pills to S1B-509

  • S1B-509 High DoseDrug

    Also called proprietary combination of trazodone and bupropion at high dose

    S1B-509 has multiple neurotransmitter activities

Study groups in NCT06517797
Study groupRoleWhat they receive
S1B-509 (proprietary combination of trazodone and bupropion) low doseExperimentalSimultaneous oral dosing once daily with two to four extended-release tablets or capsules of S1B-509, for 48 weeks
Receives: Drug: S1B-509 low dose
PlaceboPlacebo comparatorSimultaneous oral dosing once daily with two to four placebos, for 48 weeks
Receives: Drug: Placebo
S1B-509 (proprietary combination of trazodone and bupropion) high doseExperimentaltwice the dose of "S1B-509 low dose"
Receives: Drug: S1B-509 High Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Per cent weight change

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

    Measured: 48 weeks

  2. Proportion losing at least 5% body weight

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

    Measured: 48 weeks

Secondary outcomes (12)

  1. Waist circumference

    measured waist in inches or centimeters

    Measured: 48 weeks

  2. Proportion losing 10%

    per cent of patients per group losing ten percent weight, a substantial amount

    Measured: 48 weeks

  3. Proportion losing 15%

    per cent of patients per group losing a highly substantial amount of weight

    Measured: 48 weeks

  4. Change in systolic blood pressure

    average gain in systolic blood pressure per group

    Measured: 48 weeks

  5. Change in diastolic blood pressure

    average change in diastolic pressure per group

    Measured: 48 weeks

  6. Change in Hemoglobin A1c

    change in glycosylated hemoglobin, a measure of diabetes; normal is less than 6.5%

    Measured: 48 weeks

  7. Change in Columbia suicidality screener

    6 yes/no items, patient-rated screener on suicide ideation and behavior, "no" on each is best

    Measured: 48 weeks

  8. Change in Personal Health Questionnaire, 9-item version

    depression screener. Sum of 9 self-rated items from 0 (best) to 3 (worst).

    Measured: 48 weeks

  9. Adverse events

    Change in subjective (answer to "how have you felt" or objective findings

    Measured: 4 weeks

  10. Change in Female Sexual Function Index, Female

    19-item self-rated scale on sexual response, sum of ratings from 0 or 1 (worst) to 5 (best)

    Measured: 4 weeks

  11. Change in International Index of Erectile Function, 5-item version

    5-item self-rated scale on erectile function, sum of items rated from 1 (worst) to 5 (best)

    Measured: 4 weeks

  12. Edmonton Obesity Staging System

    Single-item categorical rating from 0 (normal) to 4 (severe)

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2024
  2. Study start15 Oct 2025 (estimated)
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment to putatively active treatment at low and high dose or placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06517797
Sponsor's protocol ID
S1B-509-2000
Status last verified
Jun 2025
First submitted
15 Jul 2024
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing S1B-509 low dose and S1B-509 High Dose in people with Obesity, run by S1 Biopharma, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anita Clayton, MD (4342434649, AHC8V@hscmail.mcc.virginia), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per cent weight change (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06517797.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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