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A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes

ConditionsObesityOverweight
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 diabetes. The study has two phases: a main phase and an extension phase.

Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

30 kilogram per square meter (kg/m2) OR

high blood pressure

dyslipidemia

obstructive sleep apnea, or

Disqualifiers

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)

Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)

Have type 1 diabetes or type 2 diabetes

heart attack

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

1,980 Participants
are divided into 5 treatment groups
Group A: Eloralintide Dose 1Experimental treatment 1 intervention
Group B: Eloralintide Dose 2Experimental treatment 1 intervention
Group C: Eloralintide Dose 3Experimental treatment 1 intervention
Group D: Eloralintide Dose 4Experimental treatment 1 intervention
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 64

Secondary outcomes

1

Percent Change from Baseline in Total Body Fat Mass

Time frame
Baseline, Week 64
2

Change from Baseline in Waist Circumference

Time frame
Baseline, Week 64
3

Percent Change from Baseline in Triglycerides

Time frame
Baseline, Week 64
4

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame
Baseline, Week 64

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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