A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity (NCT06965413)
A Randomized, Double-blind, Placebo-controlled Phase 2 Trial to Assess Efficacy, Safety, and Tolerability of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
🩺 Plain-English Summary (8th-Grade Level)
The main aim of the study is to assess the effect of RO7204239 in combination with tirzepatide, compared to placebo in combination with tirzepatide, on body weight loss after 48 weeks of treatment in adults with obesity or overweight with at least one weight-related comorbidity, but without diabetes mellitus (DM). The study comprises of a 4-week screening period; a 48-week core treatment period, where all participants will receive tirzepatide as background treatment and will be randomized to one of the 4 treatment arms; a 24-week treatment extension period, where participants will stop treatment with tirzepatide and a 24-week post-treatment follow-up (FU) period.
Who can join: Review the eligibility criteria below.
Location: Pinnacle Research Group — Anniston, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (35 Sites)
Showing the first 25 of 35 sites.
- Pinnacle Research Group — Anniston, Alabama
- Encompass Clinical Research — Spring Valley, California
- K2 Medical Research-Winter Garden — Clermont, Florida
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia
- Accellacare of Duly Health and Care — Oak Lawn, Illinois
- Rochester Clinical Research — Rochester, New York
- Accellacare of Salisbury — Salisbury, North Carolina
- Accellacare of Piedmont Healthcare — Statesville, North Carolina
- Accellacare of Wilmington, LLC — Wilmington, North Carolina
- Accellacare Research of Winston Salem — Winston-Salem, North Carolina
- NexGen Research — Lima, Ohio
- Accellacare of Bristol/ Internal Medicine & Pediatrics — Bristol, Tennessee
- Accellacare of Knoxville — Knoxville, Tennessee
- Clinical Research Associates — Nashville, Tennessee
- Texas Diabetes & Endocrinology, P.A. — Austin, Texas
- Juno Research, LLC — Houston, Texas
- Consano Clinical Research — Shavano Park, Texas
- Velocity Clinical Research (Impact Research Institute) — Waco, Texas
- Manassas Clinical Research Center — Manassas, Virginia
- Centrum Medyczne ALL-MED — Krakow, Lesser Poland Voivodeship
- Penta Hospials Badania Kliniczne Gdansk — Gdansk, Pomeranian Voivodeship
- Ekamed sp. z o.o. — Lublin,
- ETG Warszawa — Warsaw,
- Universidad de Sevilla - Hospital Universitario Virgen Macarena — Seville, Barcelona
- Instituto De Investigacion Marques De Valdecilla (IDIVAL) — Santander, Cantabria
💰 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 § 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.