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New daily pill shows promise for weight loss in obesity trial

NCT ID NCT06867718

Disease control Sponsor: Regor Pharmaceuticals Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This Phase 2 study tested a once-daily pill called RGT001-075 in 267 adults who are obese or overweight with weight-related health problems like high blood pressure or sleep apnea. The goal was to see if the drug helps with weight loss and is safe. Participants took either the drug or a placebo for 36 weeks, and researchers measured changes in body weight and side effects.

What this could mean

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

Active substance
RGT001-075 (a GLP-1 agonist drug taken once daily)
What this could lead to
If successful, this could lead to a new once-daily pill for weight loss in people with obesity or overweight who also have related health issues like high blood pressure or sleep apnea.
What could go wrong
This is an early Phase 2 study with only 267 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful weight loss compared to placebo.

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

267 people

The number who actually took part.

Started

Jan 2025

Finished

Nov 2025

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 to 75 years

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: 1. Male or female, age 18-75 years (inclusive) at the time of signing informed consent. 2. Hemoglobin A1c (HbA1c) \<6.5% at screening. 3. BMI ≥30 kg/m². 4. BMI ≥27 kg/m² and \<30 kg/m² with at least 1 weight-related comorbidity: * hypertension * dyslipidemia * cardiovascular (CV) disease * obstructive sleep apnea 5. Have a stable body weight (\< 5% change) for the 3 months prior to randomization. Exclusion Criteria (Obesity Related): 1. Have obesity induced by other endocrine disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome). 2. Have a prior or planned surgical treatment for obesity. 3. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months before screening such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner. 4. Have been treated with prescribed or OTC drugs or alternative remedies that promote weight loss within the last 3 months before screening. Exclusion Criteria (Medical Conditions) 1. Diabetes. 2. Have a history of acute or chronic pancreatitis. 3. Have current symptomatic gallbladder disease or biliary disease. 4. Have known liver disease other than MASLD. 5. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC). 6. Have a serum calcitonin ≥20 pg/mL. 7. Have an eGFR \<30 mL/min/1.73 m², as determined by the central laboratory at screening. 8. Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders (e.g., schizophrenia or bipolar disorder) within the last 2 years. 9. Have had any exposure to GLP-1 analogs, or other related compounds within the prior 3 months or any prior history of clinically significant side effects from GLP-1 receptor agonist (GLP-1 RA) or other related compounds containing GLP-1.

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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

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509, United States

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069, United States

  • Angels Clinical Research

    Doral, Florida, 33122, United States

  • Angels Clinical Research

    Miami, Florida, 33126, United States

  • Javara-Privia Medical Group Gulf Coast PLLC

    The Woodlands, Texas, 77384, United States

  • Javara-Privia Medical Group, Georgia LLC

    Savannah, Georgia, 31406, United States

  • Javara-Privia Medical Group, Georgia, LLC

    Thomasville, Georgia, 31792, United States

  • Javara-Tryon Medical Partners, PLLC

    Charlotte, North Carolina, 28287, United States

  • Mankato Clinic-East Main Street-Javara

    Mankato, Minnesota, 56001, United States

  • Optimal Research

    Melbourne, Florida, 32934, United States

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014, United States

  • Premier Health Research-Sparta-Objective Health

    Sparta, New Jersey, 07871, United States

  • Synexus Clinical Research

    Phoenix, Arizona, 85020, United States

  • Synexus Clinical Research

    The Villages, Florida, 32162, United States

  • Synexus Clinical Research

    Evansville, Indiana, 47714, United States

  • Synexus Clinical Research

    Richfield, Minnesota, 55423, United States

  • Synexus Clinical Research

    Creve Coeur, Missouri, 63141, United States

  • Synexus Clinical Research

    Dallas, Texas, 75234, United States

  • Synexus Clinical Research

    San Antonio, Texas, 78229, United States

  • Synexus Clinical Research

    Salt Lake City, Utah, 84106, United States

  • Velocity Clinical Research

    Huntington Park, California, 90255, United States

  • Velocity Clinical Research

    Valparaiso, Indiana, 46383, United States

  • Velocity Clinical Research

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research

    Rockville, Maryland, 20854, United States

  • Velocity Clinical Research

    Omaha, Nebraska, 68134, United States

  • Velocity Clinical Research

    Vestal, New York, 13850, United States

  • Velocity Clinical Research

    Durham, North Carolina, 27701, United States

  • Velocity Clinical Research

    Cincinnati, Ohio, 45246, United States

  • Velocity Clinical Research

    Cleveland, Ohio, 44122, United States

  • Velocity Clinical Research

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research

    Waco, Texas, 76710, United States

  • Velocity Clinical Research

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research

    Seattle, Washington, 98105, United States

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