Semaglutide for Low Back Pain

Conditions

• Chronic Lower Back Pain
• Lower Back Pain
• Obesity (BMI>30)
• glp1 Agonist

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide (administered by PDS290 pen-injector) — DRUG
  Semaglutide 3.0 mg/mL solution for subcutaneous injection, administered using a 3 mL PDS290 pen-injector. Administered subcutaneously once weekly on the same day each week, without regard to meals. Dose escalation: 0.24 mg weekly for 28 days, then increased to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg every 4 weeks to reach the maintenance dose of 2.4 mg. The pen uses a drum scale of 1-80 (in increments of 1); corresponding dose counter values are: 0.24 mg = 8, 0.5 mg = 17, 1.0 mg = 34, 1.7 mg = 57, 2.4 mg = 80. Treatment duration is 52 weeks.
• Placebo (administered by PDS290 pen-injector) — DRUG
  Matching placebo solution for subcutaneous injection, administered using a 3 mL PDS290 pen-injector. Administered subcutaneously once weekly on the same day each week, without regard to meals, following the same escalating dose counter schedule as the active comparator (counter values: 8, 17, 34, 57, 80 every 4 weeks). Treatment duration is 52 weeks.

Study Details

Low back pain is the leading cause of disability in the United States, and obesity is a major risk factor for its development. GLP-1 receptor agonists such as Semaglutide have emerged as effective weight loss agents that may also reduce chronic pain through weight reduction and other mechanisms. This randomized, double-blind, placebo-controlled trial will enroll 250 adults with chronic low back pain and obesity, randomized 1:1 to weekly Semaglutide 2.4 mg or placebo for 52 weeks. The primary outcome is change in low back pain severity, with secondary outcomes including pain-related disability and quality of life.

Key Dates

First listed

Jul 28, 2026

Start date

Feb 1, 2027

Status verified

Jul 2026

Primary completion

Jan 1, 2031

Completion

Sep 1, 2031

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Semaglutide Group
  The experimental group will receive Semaglutide 2.4 mg subcutaneously administered on the same day weekly at any time of the day without regard to meals. To achieve the weekly 2.4 mg maintenance dose, subjects will start at 0.24 mg weekly for 28 days and then increase to 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg every 4 weeks. The clinical pen is a 3 mL PDS290 pen-injector containing Semaglutide 3.0 mg/mL for subcutaneous use. Treatment duration is 52 weeks.
• Placebo Comparator: Placebo Group
  The placebo group will receive a matched placebo administered subcutaneously on the same day weekly at any time of the day without regard to meals, following the same escalating dose schedule as the active comparator. The clinical pen is a 3 mL PDS290 pen-injector containing placebo solution for subcutaneous use. Treatment duration is 52 weeks.

Primary Outcome Measure

BPI-SF Pain Severity Scale [ Time Frame: Baseline, up to 52 weeks ]

Central Contacts

• Elizabeth Wilson, MS, CCRP
  314-722-0896
  [email protected]
• Faraz Arkam, MD
  314-273-9224
  [email protected]

Locations (2)

Find similar trials in Birmingham, AL

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