A Study of LY3437943 in Participants With Type 2 Diabetes

Lilly

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes

Treatments

Drug: LY3437943

Drug: Dulaglutide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04867785

J1I-MC-GZBD (Other Identifier)

17774

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of LY3437943 in participants with type 2 diabetes (T2D) who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin. This study will last about 43 weeks.

Enrollment

281 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have Type 2 Diabetes (T2D)
Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or with a stable dose of metformin (either immediate release or extended release, 1000 milligram (mg)/day and not more than the locally approved dose) for at least 3 months prior to screening.

Exclusion criteria

Have type 1 diabetes mellitus (T1DM)
Have ketoacidosis
Have retinopathy, maculopathy
Have history of pancreatitis
Have obesity induced by other endocrine disorders
Have uncontrolled hypertension
Have acute or chronic hepatitis
Have chronic kidney disease
Have an autoimmune abnormality for example, lupus or rheumatoid arthritis
Have an active or untreated malignancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

281 participants in 8 patient groups, including a placebo group

0.5 milligrams (mg) LY3437943

Experimental group

Description:

Participants received 0.5 mg LY3437943 administered as SC (subcutaneous) injection once weekly (QW).

Treatment:

Drug: LY3437943

4 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

4 mg LY3437943 (4 mg)

Experimental group

Description:

Participants received 4 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

8 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943 and then 8 mg LY3437943 administered as SC injection QW.

Treatment:

Drug: LY3437943

8 mg LY3437943 (4 mg)

Experimental group

Description:

Participants received 4 mg LY3437943 starting dose followed by 8 mg LY3437943 administered as a SC injection QW.

Treatment:

Drug: LY3437943

12 mg LY3437943 (2 mg)

Experimental group

Description:

Participants received 2 mg LY3437943 starting dose followed by 4 mg LY3437943, then 8 mg LY3437943, then 12 mg LY3437943 administered as a SC injection QW.

Treatment:

Drug: LY3437943

1.5 mg Dulaglutide

Active Comparator group

Description:

Participants received 1.5 mg dulaglutide administered as SC single-dose pen injection QW.

Treatment:

Drug: Dulaglutide

Placebo

Placebo Comparator group

Description:

Participants received placebo administered as SC injection QW.