Semaglutide for Low Back Pain

What Was Tested

In this phase 2 trial, researchers set out to test Semaglutide for chronic pain: fibromyalgia & crps.

Low back pain is the leading cause of disability in the United States, and obesity is a major risk factor for its development.

It had two arms (groups): Semaglutide Group (active comparator) and Placebo Group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 250 planned participants were the target.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to provide informed consent before any trial-related activities. Age: 18-85 years. Chronic low back pain, defined as an average low back pain severity of at least 4/10 present on most days for 3 months or longer. BMI: 30-49 kg/m2.

The full record lists 4 inclusion and 28 exclusion criteria; among the exclusions: known or suspected allergy to trial medication(s), excipients, or related products; contraindications to study medication(s), worded specifically as stated in the product's prescribing information; previous randomization in this trial.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The chronic pain: fibromyalgia & crps participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the chronic pain: fibromyalgia & crps participants stayed in one arm throughout.

Neither the chronic pain: fibromyalgia & crps participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2027-02-01 with completion listed for 2031-01-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: BPI-SF Pain Severity Scale (time frame: Baseline, up to 52 weeks).

It also tracked 12 secondary outcomes, for example BPI-SF Pain Interference, Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS) and Mental Component Summary (MCS), PROMIS Depression, Pain Catastrophizing Scale and Insomnia Severity Index.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 250 people with chronic pain: fibromyalgia & crps.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Chronic pain: fibromyalgia & CRPS research.