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

Part of paid clinical trials in Gardena, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06373146
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Mibavademab — DRUG
    Administered SC
  • Tirzepatide-Placebo — DRUG
    Administered SC
  • Mibavademab-Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Apr 24, 2024
Status verified
May 2026
Primary completion
Dec 15, 2025
Completion
Apr 2, 2026

Study Design

Enrollment
392 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]
    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.
  • Experimental: TZP + Mibavademab-placebo (MIBA-PBO) [Group B]
    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.
  • Experimental: TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]
    Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
  • Experimental: TZP + MIBA [Group D]
    Participants will receive TZP SC + MIBA SC for 48 weeks.
  • Experimental: TZP + MIBA-PBO [Group E]
    Participants will receive TZP SC + MIBA-PBO SC for 48 weeks.
  • Experimental: TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
    Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
  • Experimental: TZP + MIBA-PBO then TZP + MIBA [Group G]
    Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
  • Experimental: TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]
    Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.

Primary Outcome Measure

Mean Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 48 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Velocity Clinical Research, GardenaGardenaCalifornia90247-
Irvine Clinical ResearchIrvineCalifornia92614-
Velocity Clinical Research, Los AngelesLos AngelesCalifornia90017-
Velocity Clinical Research, North HollywoodNorth HollywoodCalifornia91606-
Velocity Clinical Research, Santa AnaSanta AnaCalifornia92704-
Velocity Clinical Research, Panorama CityVan NuysCalifornia91405-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Solaris Clinical ResearchMeridianIdaho83646-
Tandem Clinical ResearchMarreroLouisiana70072-
Velocity Clinical Research - New OrleansNew OrleansLouisiana70119-
Hassman Research Institute Marlton SiteMarltonNew Jersey08053-
Lillestol ResearchFargoNorth Dakota58104-
CTI Clinical Research CenterCincinnatiOhio45212-
South Texas Clinical ResearchCorpus ChristiTexas78404-
Velocity Clinical Research, DallasDallasTexas75230-
Juno ResearchHoustonTexas77040-
Northwest Clinical Research CenterBellevueWashington98007-

Find similar trials in Gardena, CA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Velocity Clinical Research, Gardena· Gardena, CAIrvine Clinical Research· Irvine, CAVelocity Clinical Research, Los Angeles· Los Angeles, CAVelocity Clinical Research, North Hollywood· North Hollywood, CAVelocity Clinical Research, Santa Ana· Santa Ana, CAVelocity Clinical Research, Panorama City· Van Nuys, CA

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