๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-27

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity (NCT07497880)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

๐ŸŸข Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Kailera

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Kailera Clinical Site โ€” Chandler, Arizona

Age range: 18 Years to 75 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (36 Sites)

Showing the first 25 of 36 sites.

  • Kailera Clinical Site โ€” Chandler, Arizona
  • Kailera Clinical Site โ€” Phoenix, Arizona
  • Kailera Clinical Site โ€” Irvine, California
  • Kailera Clinical Site โ€” Lincoln, California
  • Kailera Clinical Site โ€” Northridge, California
  • Kailera Clinical Site โ€” Hamden, Connecticut
  • Kailera Clinical Site โ€” Jacksonville, Florida
  • Kailera Clinical Site โ€” Jupiter, Florida
  • Kailera Clinical Site โ€” Palm Springs, Florida
  • Kailera Clinical Site โ€” Pembroke Pines, Florida
  • Kailera Clinical Site โ€” Decatur, Georgia
  • Kailera Clinical Site โ€” Chicago, Illinois
  • Kailera Clinical Site โ€” Skokie, Illinois
  • Kailera Clinical Site โ€” South Bend, Indiana
  • Kailera Clinical Site โ€” Kenner, Louisiana
  • Kailera Clinical Site โ€” Garden City, Michigan
  • Kailera Clinical Site โ€” Jefferson City, Missouri
  • Kailera Clinical Site โ€” Kansas City, Missouri
  • Kailera Clinical Site โ€” Spartanburg, South Carolina
  • Kailera Clinical Site โ€” Knoxville, Tennessee
  • Kailera Clinical Site โ€” Austin, Texas
  • Kailera Clinical Site โ€” Austin, Texas
  • Kailera Clinical Site โ€” Brownsville, Texas
  • Kailera Clinical Site โ€” Farmers Branch, Texas
  • Kailera Clinical Site โ€” Fort Worth, Texas

๐Ÿ“ž Contact the Study Coordinator

Phone: (781) 317-0291

Email: info-clinicalstudies@kailera.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Obesity clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—