A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT06124807
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide — DRUG
    Administered subcutaneous (SC)
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with Mazdutide compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

Key Dates

Start date
Nov 17, 2023
Status verified
Mar 2026
Primary completion
Jan 22, 2025
Completion
Jul 9, 2025

Study Design

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

Arms

  • Experimental: 3/6 Milligrams (mg) Mazdutide
    Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (3 or 6 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-31, then 6 mg from Weeks 32-48.
  • Experimental: 10 mg Mazdutide
    Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (10 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 8 mg from Weeks 12-15, and then 10 mg from Weeks 16-48.
  • Experimental: 16 mg Mazdutide
    Participants received once-weekly subcutaneous Mazdutide with dose escalation until the target dose (16 mg) was achieved, starting at 1.5 mg from Weeks 0-3, followed by 3 mg from Weeks 4-7, 6 mg from Weeks 8-11, 9 mg from Weeks 12-15, 12 mg from Weeks 16-19, and then16 mg from Weeks 20-48.
  • Placebo Comparator: Placebo
    Participants received Mazdutide matched placebo subcutaneously once weekly from Weeks 0 to 48.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 32 [ Time Frame: Baseline, Week 32 ]

Locations (29)

FacilityCityStateZIPSite coordinators
The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandlerArizona85225-
Headlands Research - ScottsdaleScottsdaleArizona85260-
The Institute for Liver Health II dba Arizona Liver Health-TucsonTucsonArizona85712-
Velocity Clinical Research, Huntington ParkHuntington ParkCalifornia90255-
Peninsula Research AssociatesRolling Hills EstatesCalifornia90274-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Northeast Research Institute (NERI)Fleming IslandFlorida32003-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Charter Research - Winter ParkOrlandoFlorida32803-
Charter Research - Lady LakeThe VillagesFlorida32162-
Pacific Diabetes & Endocrine CenterHonoluluHawaii96817-
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640-
Great Lakes Clinical Trials - RavenswoodChicagoIllinois60640-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
L-MARC Research CenterLouisvilleKentucky40213-
KnownwellNeedhamMassachusetts02492-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Las Vegas Medical ResearchLas VegasNevada89128-
Dent Neurologic InstituteAmherstNew York14226-
North Suffolk NeurologyPort Jefferson StationNew York11776-
Lucas Research, Inc.New BernNorth Carolina28562-
CTI Clinical Research CenterCincinnatiOhio45212-
Quality Medical ResearchNashvilleTennessee37211-
IMA Clinical Research AustinAustinTexas78745-
Velocity Clinical Research, DallasDallasTexas75230-
PlanIt Research, PLLCHoustonTexas77079-
Tekton Research - Fredericksburg RoadSan AntonioTexas78229-
Spectrum Medical, Inc.DanvilleVirginia24541-
Central Washington Health Services Association d/b/a Confluence HealthWenatcheeWashington98801-

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