A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes

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 for body weight reduction in participants with overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have type 2 diabetes

Are on stable treatment for type 2 diabetes for at least 90 days prior to screening

Have a BMI ≥ 27 kg/m2

Have a stable body weight (<5% body weight change) for 90 days prior to screening

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

amylin analogs

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

1,035 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

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame
Baseline, Week 64
4

Percent Change in Baseline in Triglycerides

Time frame
Baseline, Week 64

Other outcomes

Sponsors and contacts

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