Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Kailera
Study ID
NCT07284875
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • KAI-9531 — DRUG
    SC Injection
  • Placebo — DRUG
    SC Injection

Study Details

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

Key Dates

Start date
Dec 18, 2025
Status verified
Jun 2026
Primary completion
Feb 28, 2028
Completion
Mar 27, 2028

Study Design

Enrollment
1,800 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.
  • Experimental: KAI-9531: Dose 3
    Participants will receive Dose 3 of KAI-9531 once weekly.
  • Experimental: KAI-9531: Dose 4
    Participants will receive Dose 4 of KAI-9531 once weekly.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to KAI-9531 once weekly.

Primary Outcome Measure

Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [ Time Frame: Baseline, Week 76 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Kailera Clinical SiteAnnistonAlabama36207-
Kailera Clinical SiteBirminghamAlabama35294-
Kailera Clinical SiteCullmanAlabama35055-
Kailera Clinical SiteSun CityArizona85351-
Kailera Clinical SiteEscondidoCalifornia92025-
Kailera Clinical SiteToluca LakeCalifornia91602-
Kailera Clinical SiteAuroraColorado80012-
Kailera Clinical SiteBridgeportConnecticut06606-
Kailera Clinical SiteJupiterFlorida33458-
Kailera Clinical SiteLilburnGeorgia30047-
Kailera Clinical SiteSpringfieldIllinois62072-
Kailera Clinical SiteColumbiaMaryland21045-
Kailera Clinical SiteLas VegasNevada89119-
Kailera Clinical SiteRochesterNew York14609-
Kailera Clinical SiteMorehead CityNorth Carolina28557-
Kailera Clinical SiteChickashaOklahoma73018-
Kailera Clinical SiteMauldinSouth Carolina29662-
Kailera Clinical SiteChattanoogaTennessee37405-
Kailera Clinical SiteAmarilloTexas79124-
Kailera Clinical SiteDeSotoTexas75115-
Kailera Clinical SiteTomballTexas77375-
Kailera Clinical SiteSalt Lake CityUtah84124-
Kailera Clinical SiteDanvilleVirginia24541-

Find similar trials in Anniston, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Kailera Clinical Site· Anniston, ALKailera Clinical Site· Birmingham, ALKailera Clinical Site· Cullman, ALKailera Clinical Site· Sun City, AZKailera Clinical Site· Escondido, CAKailera Clinical Site· Toluca Lake, CA

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