Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Kailera
Study ID
NCT07497880
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • KAI-7535 — DRUG
    Oral tablets
  • Placebo — DRUG
    Oral tablets

Study Details

The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.

Key Dates

Start date
Apr 6, 2026
Status verified
Jun 2026
Primary completion
Jul 7, 2027
Completion
Jul 7, 2027

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KAI-7535: Dose Schedule 1
    Participants will receive KAI-7535 once daily.
  • Experimental: KAI-7535: Dose Schedule 2
    Participants will receive KAI-7535 once daily.
  • Experimental: KAI-7535: Dose Schedule 3
    Participants will receive KAI-7535 once daily.
  • Experimental: KAI-7535: Dose Schedule 4
    Participants will receive KAI-7535 once daily.
  • Placebo Comparator: Placebo
    Participants will receive placebo matched to KAI-7535 once daily.

Primary Outcome Measure

Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus [ Time Frame: Baseline, Week 44 ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Kailera Clinical SiteChandlerArizona85225-
Kailera Clinical SiteIrvineCalifornia92614-
Kailera Clinical SiteLincolnCalifornia95648-
Kailera Clinical SiteNorthridgeCalifornia91325-
Kailera Clinical SiteHamdenConnecticut06517-
Kailera Clinical SiteJupiterFlorida33458-
Kailera Clinical SitePembroke PinesFlorida33024-
Kailera Clinical SiteDecaturGeorgia30030-
Kailera Clinical SiteSkokieIllinois60077-
Kailera Clinical SiteSouth BendIndiana46617-
Kailera Clinical SiteKennerLouisiana70065-
Kailera Clinical SiteGarden CityMichigan48135-
Kailera Clinical SiteJefferson CityMissouri65109-
Kailera Clinical SiteKansas CityMissouri64151-
Kailera Clinical SiteKnoxvilleTennessee37909-
Kailera Clinical SiteAustinTexas78757-
Kailera Clinical SiteBrownsvilleTexas78520-
Kailera Clinical SiteFarmers BranchTexas75234-
Kailera Clinical SiteSan AntonioTexas78229-

Find similar trials in Chandler, AZ

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Kailera Clinical Site· Chandler, AZKailera Clinical Site· Irvine, CAKailera Clinical Site· Lincoln, CAKailera Clinical Site· Northridge, CAKailera Clinical Site· Hamden, CTKailera Clinical Site· Jupiter, FL

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