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New weekly shot shows promise for major weight loss

NCT ID NCT06525935

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new drug called enicepatide (CT-388) given as a weekly injection for 48 weeks. It involved 469 adults with obesity or overweight who also had at least one weight-related health problem like high blood pressure or prediabetes. The goal was to see how much weight people lost and whether the drug was safe and tolerable.

What this could mean

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

Active substance
Enicepatide (also called CT-388), a once-weekly injectable drug
What this could lead to
If successful, this could lead to a new weekly injection for significant weight loss in people with obesity or overweight and related health issues.
What could go wrong
This is a Phase 2 dose-finding study, so results are still early. The drug may cause side effects or fail to show enough benefit over 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

469 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 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: * Male or female, 18 to 75 years of age * Body mass index (BMI) ≥30.0 kg/m2, OR BMI ≥27.0 and \<30.0 kg/m2 and previously diagnosed with at least 1 of the following weight-related comorbidities, such as: prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease * At least one self-reported unsuccessful effort to lose body weight Exclusion Criteria: * Prior history/diagnosis/lab evidence of any type of diabetes mellitus (e.g., Type 1, Type 2, gestational), or a history of ketoacidosis or hyperosmolar state * Self-reported body weight change of \>5 kg within 3 months before randomization * Any unbalanced/extreme diets within 3 months of the screening visit, or plan to be on such diets during the study * Current or recent participation in an organized weight reduction program * Current or recent use of any treatment that promotes weight loss or glucose metabolism * Current or recent use of treatment that may cause weight gain * Prior or planned surgical treatment for obesity * Clinically significant or active gastric emptying abnormality, malabsorption, or chronic use of medications that directly affect GI motility * History of chronic pancreatitis or acute pancreatitis within 6 months before screening * Have obesity induced by other endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity * History of major depressive disorder within 2 years of screening, or any history/diagnosis of other severe psychiatric conditions (Note: Prospective participants with depression or anxiety whose disease state, in the opinion of the Investigator, is considered stable and expected to remain stable throughout the course of the study, may be considered for inclusion) * Family or personal history of medullary thyroid carcinoma * Serum calcitonin ≥ 20 ng/L * Women who are pregnant, breastfeeding, or intend to become pregnant, or are of childbearing potential and not using a highly effective contraceptive method

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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.

Contacts and locations

Locations

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920, United States

  • Amicis Research Center

    Northridge, California, 91324, United States

  • Amicis Research Center - Anaheim

    Anaheim, California, 92801, United States

  • Amicis Research Center - West Hills

    West Hills, California, 91307, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Ark Clinical Research - Long Beach

    Long Beach, California, 90806, United States

  • Ark Clinical-Fountain Valley

    Fountain Valley, California, 92708, United States

  • Central Alabama Research

    Homewood, Alabama, 35209, United States

  • Chrysalis Clinical Research

    St. George, Utah, 84790, United States

  • Clinical Research Associates, Inc.

    Nashville, Tennessee, 37203, United States

  • Elevate Clinical

    Seabrook, Texas, 77586, United States

  • FutureSearch Trials of Dallas, LLC

    Dallas, Texas, 75231, United States

  • Impact Research Institute

    Waco, Texas, 76710, United States

  • Infinity Clinical Research

    Norco, California, 92860, United States

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213, United States

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557, United States

  • Mercury Street Medical Group

    Butte, Montana, 59701, United States

  • National Clinical Research - Richmond, Inc

    Richmond, Virginia, 23294, United States

  • Neurobehavioral Research, Inc. (NBR)

    Cedarhurst, New York, 11516, United States

  • Orange County Research Center

    Tustin, California, 92780, United States

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229, United States

  • Progressive Medical Research

    Port Orange, Florida, 32127, United States

  • Prospective Research Innovations Inc.

    Rancho Cucamonga, California, 91730, United States

  • Tampa Bay Medical Research, Inc.

    Clearwater, Florida, 33761, United States

  • Texas Diabetes & Endocrinology, P.A.

    Austin, Texas, 78731, United States

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114, United States

  • The Institute for Liver Health II LLC dba Arizona Clinical Trials; Arizona Liver Health

    Mesa, Arizona, 85210, United States

  • Tribe Clinical Research

    Greenville, South Carolina, 29607, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - Dallas

    Dallas, Texas, 75230, United States

  • Velocity Clinical Research - Los Angeles

    Los Angeles, California, 90057, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818, United States

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