Skip to main content
Delfa

← All trials/NCT06215196

ESSENCE

CompletedPhase NA

Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial

Lead sponsor

S.LAB (SOLOWAYS)

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

81

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06215196
Org study IDSW004

Timeline

Milestones

Study start2023-04-14actual
Primary completion2023-06-28actual
Study completion2023-08-20actual
Study first posted2024-01-22actual
Last update posted2024-01-23actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥30, or ≥27 with comorbidities.

Exclusion criteria

•Serious chronic illnesses.
•History of bulimia or anorexia.
•Pregnancy or lactation.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
7
Safety / tolerability / PK
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Percentage change in body weight from baseline

Time frame:180 days

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Achievement of a reduction in body weight of 5% or more from baseline.

Time frame:180 days

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

BMI change

Time frame:180 days

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

fat mass change

Time frame:180 day

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

fat-free mass change

Time frame:180 days

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

visceral fat rating change

Time frame:180 days

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

total body water change

Time frame:180 days

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Safety evaluated by recording any adverse events.

Time frame:180 days

Treatment-emergent AEs (any)

descriptive

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.