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

S.LAB (SOLOWAYS)

Status: Completed

Conditions: Overweight and Obesity

Treatments: Other: placebo; Dietary Supplement: Fiber Supplement Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06215196

SW004

Details and patient eligibility

About

This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.

Enrollment: 81 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI ≥30, or ≥27 with comorbidities.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups, including a placebo group

Semaglutide with Active Fiber Supplement Group

Experimental group

Treatment:

Dietary Supplement: Fiber Supplement Group

Placebo group

Placebo Comparator group

Treatment:

Other: placebo