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New daily pill could help millions shed pounds without diabetes

NCT ID NCT07081958

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Updated 3 times

Summary

This study tests a new once-daily pill called RO7795081 for weight loss in adults with obesity or overweight who also have weight-related health problems like high blood pressure or sleep apnea. The trial involves 352 participants and lasts 38 weeks, comparing the drug to a placebo. The main goal is to see how much weight people lose after 30 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RO7795081 (an oral drug for weight management)
What this could lead to
If successful, this could lead to a new once-daily pill to help people with obesity or overweight lose weight and improve related health conditions.
What could go wrong
This is an early Phase 2 trial, so the drug may not prove effective or safe enough for approval. Side effects and long-term risks are still unknown.

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

352 people

The number who actually took part.

Started

Jul 2025

Finished

Jul 2026

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: * Participants must have at screening: 1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\^2; or 2. BMI ≥27.0 kg/m\^2 and \<30.0 kg/m\^2 with at least one weight-related comorbidity, such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease * History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight * A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss) Exclusion Criteria: * Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes \[T1D\], T2D, or rare forms of diabetes) * Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome) * Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study * Prior or planned surgical treatment for obesity * Have a known, clinically significant gastric emptying abnormality * Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension * Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure. * Have a history of acute or chronic pancreatitis * Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder), or had a suicide attempt within the last 1 year of screening

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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 or overweight

Contacts and locations

Locations

  • Accellacare - Hickory

    Hickory, North Carolina, 28601, United States

  • Accellacare Research of Winston Salem

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare of Cary - Cary Medical Group

    Cary, North Carolina, 27518, 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 Raleigh

    Raleigh, North Carolina, 27609, United States

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804, United States

  • Accellacare of Salisbury

    Salisbury, North Carolina, 28144, United States

  • Accellacare of Wilmington, LLC

    Wilmington, North Carolina, 28401, United States

  • Alliance for Multispecialty Research, LLC (AMR Norman)

    Norman, Oklahoma, 73069, United States

  • Alliance for Multispecialty Research. LLC

    Knoxville, Tennessee, 37909, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Asclepes Research Centers

    Sherman Oaks, California, 91403, United States

  • Chase Medical Research

    Waterbury, Connecticut, 06708-3346, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Research Associates

    Nashville, Tennessee, 37203, United States

  • Consano Clinical Research

    Shavano Park, Texas, 78231, United States

  • Emerson Clinical Research Institute LLC

    Washington D.C., District of Columbia, 20009, United States

  • Encompass Clinical Research

    Spring Valley, California, 91978, United States

  • Internal Medicine and Pediatrics Associates of Bristol

    Bristol, Tennessee, 37620, United States

  • Juno Research, LLC

    Houston, Texas, 77040, United States

  • K2 Medical Research-Maitland

    Maitland, Florida, 32751, United States

  • K2 Medical Research-Winter Garden

    Clermont, Florida, 34711, United States

  • Knoxville-Summit-Halls Family Practice

    Knoxville, Tennessee, 37938, United States

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110, United States

  • McFarland Clinic under Accellacare

    Ames, Iowa, 50010, United States

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701, United States

  • Neurobehavioral Research, Inc.

    Cedarhurst, New York, 11516, United States

  • Orange County Research Center

    Lake Forest, California, 92630, United States

  • Pinnacle Research Group

    Anniston, Alabama, 36207, United States

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730, United States

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731, United States

  • Tristar Clinical Investigations

    Philadelphia, Pennsylvania, 19114, United States

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

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