Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Kailera
Study ID
NCT07284979
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Key Dates

Start date
Dec 30, 2025
Status verified
Jun 2026
Primary completion
Mar 20, 2028
Completion
Apr 17, 2028

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KAI-9531: Dose 1
    Participants will receive Dose 1 of KAI-9531 once weekly.
  • Experimental: KAI-9531: Dose 2
    Participants will receive Dose 2 of KAI-9531 once weekly.
  • Active Comparator: Semaglutide
    Participants will receive semaglutide once weekly.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to KAI-9531 once weekly.

Primary Outcome Measure

Percent Change From Baseline in Body Weight at Week 76 [ Time Frame: Baseline, Week 76 ]

Central Contacts

Locations (26)

FacilityCityStateZIPSite coordinators
Kailera Clinical SiteGlendaleArizona85308-
Kailera Clinical SitePhoenixArizona85012-
Kailera Clinical SiteLittle RockArkansas72205-
Kailera Clinical SiteNorthridgeCalifornia91325-
Kailera Clinical SiteOceansideCalifornia92058-
Kailera Clinical SiteHamdenConnecticut06517-
Kailera Clinical SiteStamfordConnecticut06905-
Kailera Clinical SiteOrange CityFlorida32763-
Kailera Clinical SiteAlbanyGeorgia31707-
Kailera Clinical SiteChicagoIllinois60640-
Kailera Clinical SiteSkokieIllinois60077-
Kailera Clinical SiteNewtonKansas67114-
Kailera Clinical SiteShreveportLouisiana71105-
Kailera Clinical SiteFarmington HillsMichigan48334-
Kailera Clinical SiteMissoulaMontana59804-
Kailera Clinical SiteLas VegasNevada89148-
Kailera Clinical SiteAlbanyNew York12203-
Kailera Clinical SiteMorehead CityNorth Carolina28557-
Kailera Clinical SiteNormanOklahoma73069-
Kailera Clinical SiteEast GreenwichRhode Island02818-
Kailera Clinical SiteNorth CharlestonSouth Carolina29405-
Kailera Clinical SiteSpartanburgSouth Carolina29303-
Kailera Clinical SiteBrownsvilleTexas78526-
Kailera Clinical SiteSan AntonioTexas78229-
Kailera Clinical SiteManassasVirginia20110-
Kailera Clinical SiteRichmondVirginia23236-

Find similar trials in Glendale, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Kailera Clinical Site· Glendale, AZKailera Clinical Site· Phoenix, AZKailera Clinical Site· Little Rock, ARKailera Clinical Site· Northridge, CAKailera Clinical Site· Oceanside, CAKailera Clinical Site· Hamden, CT

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