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New drug combo aims to boost weight loss in obesity trial

NCT ID NCT06965413

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests whether adding an experimental drug (RO7204239) to an existing weight-loss medication (tirzepatide) helps adults with obesity or overweight lose more weight over 48 weeks. About 285 participants without diabetes will receive either the combination or a placebo plus tirzepatide. The goal is to see if the combination is safe and more effective for weight loss.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

285 people

The number who actually took part.

Started

May 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * BMI ≥ 30.0 kilograms per square meter (kg/m²) (additional weight-related comorbidities are not required for inclusion) * BMI ≥ 27.0 kg/m² and \< 30.0 kg/m² with at least one weight-related comorbidity such as: hypertension, dyslipidemia, obstructive sleep apnea and any cardiovascular disease * History of at least one self-reported unsuccessful dietary or exercise effort to lose body weight * Weight stability: self-reported change in body weight less than 5 kilograms (kg) (11 pounds \[lbs\]) within 3 months prior to screening Exclusion Criteria: * Prior history or diagnosis of DM * Presence of non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular edema * Have obesity induced by other endocrinologic disorders * Participation in unbalanced/extreme diets * Prior or planned surgical treatment for obesity * Endoscopic and/or device-based therapy for obesity or device removal within 6 months prior to screening * Have a known clinically significant gastric emptying abnormality * Have any of the following cardiovascular conditions within 6 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF) * Have evidence of significant active, uncontrolled cardiovascular, autoimmune, endocrine, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, a neurological or psychiatric condition, or a history of any neuromuscular disorder or autoimmune/inflammatory disorders that may cause muscle wasting or medical condition capable of constituting a risk when taking the study medication or interfering with the interpretation of data, as judged by the investigator at screening * Have evidence of a significant, uncontrolled endocrine abnormality * Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy * Have evidence of a significant, active autoimmune abnormality * Have anemia * Have signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease * Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity Overweight Overweight with one weight related comorbidity

Contacts and locations

Locations

  • Accellacare North London

    Northwood, HA6 2RN, United Kingdom

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare South London

    Orpington, BR5 3QG, United Kingdom

  • Accellacare Warwickshire

    Coventry, CV3 4FJ, United Kingdom

  • Accellacare Yorkshire

    Shipley, Yorkshire, BD18 3SA, United Kingdom

  • Accellacare of Bristol/ Internal Medicine & Pediatrics

    Bristol, Tennessee, 37620, United States

  • Accellacare of Duly Health and Care

    Oak Lawn, Illinois, 60453, United States

  • Accellacare of Knoxville

    Knoxville, Tennessee, 37912, United States

  • Accellacare of Piedmont Healthcare

    Statesville, North Carolina, 28625, United States

  • Accellacare of Salisbury

    Salisbury, North Carolina, 28144, United States

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina, 28401, United States

  • Centrum Medyczne ALL-MED

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Consano Clinical Research

    Shavano Park, Texas, 78231, United States

  • ETG Warszawa

    Warsaw, 02-677, Poland

  • Ekamed sp. z o.o.

    Lublin, 20-718, Poland

  • Encompass Clinical Research

    Spring Valley, California, 91978, United States

  • Fylde Coast Clinical Research at Layton Medical Centre

    Blackpool, Lancashire, FY3 7EN, United Kingdom

  • Hospital San Rafael A Coruna

    A Coruña, LA Coruna, 15006, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Hospital Vithas Nisa Sevilla

    Castilleja de la Cuesta, Granada, 41950, Spain

  • Instituto De Investigacion Marques De Valdecilla (IDIVAL)

    Santander, Cantabria, 39008, Spain

  • Juno Research, LLC

    Houston, Texas, 77040, United States

  • K2 Medical Research-Winter Garden

    Clermont, Florida, 34711, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • NexGen Research

    Lima, Ohio, 45801, United States

  • Penta Hospials Badania Kliniczne Gdansk

    Gdansk, Pomeranian Voivodeship, 80-546, Poland

  • Pinnacle Research Group

    Anniston, Alabama, 36207, United States

  • Rochester Clinical Research

    Rochester, New York, 14609, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731, United States

  • Universidad de Sevilla - Hospital Universitario Virgen Macarena

    Seville, Barcelona, 41009, Spain

  • University Hospitals of Leicester NHS Trust - Leicester General Hospital (LGH)

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Velocity Clinical Research (Impact Research Institute)

    Waco, Texas, 76710, United States

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Other studies related to the condition(s) this trial covers.