A Study of LY3502970 in Participants With Type 2 Diabetes Mellitus

Recruiting at 53 trial locations

Overseen By There may be multiple sites in this clinical trial. 10877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Metformin

Must not be taking: GI motility drugs

Disqualifiers: Type 1 diabetes, Pancreatitis, Hypertension, Heart conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

383 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on a stable dose of metformin if they are using it. Hormone replacement therapy is allowed if it has been stable for 3 months before starting the trial.

What is the purpose of this trial?

This trial is testing a new medication called LY3502970 to help people with type 2 diabetes control their blood sugar levels. It targets those who haven't had success with diet, exercise, or metformin. The study will last several months to see if LY3502970 is effective and safe.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Inclusion Criteria

Note: Hormone replacement therapy in post-menopausal women is allowed but women must be on stable therapy for 3 months prior to day 1.

You are not of childbearing potential (WNOCBP).

You have been diagnosed with Type 2 Diabetes on diet and exercise and/or a stable dose of metformin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3502970 or placebo with dose escalation over 26 weeks

26 weeks

Multiple visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Dulaglutide
• LY3502970
• Placebo

Participant Groups

Group I: 45 mg LY3502970 - 2 Experimental Treatment 1 Intervention

Participants received maintenance dose 45 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Group II: 45 mg LY3502970 - 1 Experimental Treatment 1 Intervention

Participants received maintenance dose 45 mg with dose escalation starting from 3 mg, 6 mg, 8 mg, 12 mg, 24 mg, 36 mg and then 45 mg LY3502970 administered orally QD.

Group III: 36 mg LY3502970 - 2 Experimental Treatment 1 Intervention

Participants received maintenance dose 36 mg with dose escalation starting from 3 mg, 6 mg,12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Group IV: 36 mg LY3502970 - 1 Experimental Treatment 1 Intervention

Participants received maintenance dose 36 mg with dose escalation starting from 2 mg, 3 mg, 6 mg, 8 mg, 12 mg, 24 mg and then 36 mg LY3502970 administered orally QD.

Group V: 3 milligrams (mg) LY3502970 Experimental Treatment 1 Intervention

Participants received maintenance dose of 3 mg with dose escalation starting from 2 mg LY3502970 administered orally once daily (QD).

Group VI: 24 mg LY3502970 Experimental Treatment 1 Intervention

Participants received maintenance dose 24 mg with dose escalation starting from 3 mg, 6 mg, 8 mg,12 mg and then 24 mg LY3502970 administered orally QD.

Group VII: 12 mg LY3502970 Experimental Treatment 1 Intervention

Participants received maintenance dose 12 mg with dose escalation starting from 2 mg, 6 mg and then 12 mg LY3502970 administered orally QD.

Group VIII: 1.5 mg Dulaglutide Active Control 1 Intervention

Participants received 1.5 mg Dulaglutide administered subcutaneously (SC) once weekly (QW).

Group IX: Placebo Placebo Group 1 Intervention

Participants received matching placebo.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University