A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Obesity

Treatments: Drug: Mibavademab-Placebo; Drug: Tirzepatide-Placebo; Drug: Mibavademab; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06373146

I8F-MC-GPIV (Other Identifier)

18750

Details and patient eligibility

About

The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m²
• Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention)
• Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria

• Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma
• Have a self-reported change (increase or decrease) in body weight >5 kilogram (kg) within 3 months prior to screening
• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2
• Have acute or chronic hepatitis
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 8 patient groups

Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]

Experimental group

Description:

Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24.

Treatment:

Drug: Mibavademab

Drug: Tirzepatide

TZP + Mibavademab-placebo (MIBA-PBO) [Group B]

Experimental group

Description:

Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24.

Treatment:

Drug: Tirzepatide

Drug: Mibavademab-Placebo

TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]

Experimental group

Description:

Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.

Treatment:

Drug: Mibavademab

Drug: Tirzepatide

Drug: Tirzepatide-Placebo

TZP + MIBA [Group D]

Experimental group

Description:

Participants will receive TZP SC + MIBA SC for 48 weeks.

Treatment:

Drug: Mibavademab

Drug: Tirzepatide

TZP + MIBA-PBO [Group E]

Experimental group

Description:

Participants will receive TZP SC + MIBA-PBO SC for 48 weeks.

Treatment:

Drug: Tirzepatide

Drug: Mibavademab-Placebo

TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]

Experimental group

Description:

Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.

Treatment:

Drug: Mibavademab

Drug: Tirzepatide

Drug: Tirzepatide-Placebo

Drug: Mibavademab-Placebo

TZP + MIBA-PBO then TZP + MIBA [Group G]

Experimental group

Description:

Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.

Treatment:

Drug: Mibavademab

Drug: Tirzepatide

Drug: Mibavademab-Placebo

TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]

Experimental group

Description:

Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.

Treatment:

Drug: Tirzepatide

Drug: Tirzepatide-Placebo

Drug: Mibavademab-Placebo