A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have type 2 diabetes

Have HbA1c ≥7.5% to ≤10.5% at screening

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

Have had a stable body weight for the three months prior to screening

Disqualifiers

Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma

Have a prior or planned surgical treatment for obesity

acute myocardial infarction

cerebrovascular accident (stroke)

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3457263

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: LY3457263 Dose 1Experimental treatment 1 intervention
Group B: LY3457263 Dose 2Experimental treatment 1 intervention
Group C: LY3457263 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame
Baseline, Week 24

Secondary outcomes

1

Change from Baseline in Fasting Serum Glucose

Time frame
Baseline, Week 24
2

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 24

Other outcomes

Sponsors and contacts

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