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South Texas Clinical Research | Corpus Christi, TX

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

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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 the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 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

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-PBO 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

Trial contacts and locations

24

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Central trial contact

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

Data sourced from clinicaltrials.gov

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