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A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

ConditionsObesityOverweightChronic Low Back Pain (CLBP)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a history of axial-predominant low back pain

Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs

Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening

Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

Disqualifiers

Have a non-axial origin low back pain

Have had botulinum or steroid injections to the spine within 1 year of screening

Have had trigger point injection to the spine within 6 months of screening

Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days prior to screening

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retatrutide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

586 Participants
are divided into 2 treatment groups
Group A: RetatrutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Pain Intensity Per Numeric Rating Scale

Time frame
Baseline, up to 72 weeks
2

Percent Change from Baseline in Body Weight

Time frame
Baseline, up to 72 weeks

Secondary outcomes

1

Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale

Time frame
Baseline, up to 72 weeks
2

Number of Participants with Reduction in Body Weight

Time frame
Baseline, up to 72 weeks
3

Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)

Time frame
Baseline, up to 72 weeks
4

Change in Pain Interference as Measured by PROMIS

Time frame
Baseline, up to 72 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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