Health Trials

A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin

ConditionsOverweightObesity
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 eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.

Participation in the study will last about 80 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are on stable incretin therapy at screening

≥30 kg/m2 OR

hypertension

dyslipidemia

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

dipeptidyl peptidase-4 (DPP-4) inhibitors

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

900 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

Change from Baseline in Waist Circumference

Time frame
Baseline, Week 64
2

Percent Change in Baseline in Triglycerides

Time frame
Baseline, Week 64
3

Change from Baseline in Systolic Blood Pressure

Time frame
Baseline, Week 64
4

Change from Baseline in Body Mass Index (BMI)

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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