A Study to Investigate Weight Management With Macupatide and Eloralintide, Alone or in Combination, in Adult Participants With Obesity or Overweight

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: Macupatide; Drug: Eloralintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07589608

W8M-MC-CWMM (Other Identifier)

W8M-MC-MC01 (Other Identifier)

27844

Details and patient eligibility

About

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to examine the body weight-lowering efficacy and safety of macupatide plus eloralintide compared with placebo in participants with obesity or overweight and without type 2 diabetes. Participation will last about 64 weeks.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• See Master Protocol CWMM (NCT06143956) for inclusion criteria

Exclusion criteria

In addition to exclusion criteria in Master Protocol CWMM (NCT06143956):

• Have type 1 diabetes or type 2 diabetes
• Have an ongoing history of bradyarrhythmia and/or sinus bradycardia
• Have an elevated resting pulse rate (greater than 100 bpm) or reduced resting pulse rate (less than 60 bpm)
• Have a history of acute or chronic pancreatitis
• All concomitant medications should be at a stable dose for at least 3 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 8 patient groups, including a placebo group

Macupatide Dose 1

Experimental group

Description:

Participants will receive macupatide subcutaneously (SC)

Treatment:

Drug: Macupatide

Eloralintide Dose 1

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Macupatide Dose 1 + Eloralintide Dose 1

Experimental group

Description:

Participants will receive macupatide SC and eloralintide SC

Treatment:

Drug: Eloralintide

Drug: Macupatide

Eloralintide Dose 2

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Macupatide Dose 1 + Eloralintide Dose 2

Experimental group

Description:

Participants will receive macupatide SC and eloralintide SC

Treatment:

Drug: Eloralintide

Drug: Macupatide

Eloralintide Dose 3

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Macupatide Dose 2 + Eloralintide Dose 3

Experimental group

Description:

Participants will receive macupatide SC and eloralintide SC

Treatment:

Drug: Eloralintide

Drug: Macupatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo