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New shot aims to keep Ex-Smokers from lighting up again

NCT ID NCT07223840

Symptom relief Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 4 times

Summary

This study tests a drug called brenipatide against a placebo to see if it can help adults who have recently quit smoking stay smoke-free. About 222 participants will receive injections for 24 weeks and be followed for 8 more weeks. The main goal is to see if more people remain abstinent from cigarettes with brenipatide than with placebo.

What this could mean

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

Active substance
brenipatide
What this could lead to
If it works, this could offer a new medication to help people who have quit smoking avoid relapsing.
What could go wrong
This is an early Phase 2 trial with only 222 participants, so results may not apply broadly. The drug may not prove more effective than placebo, and side effects are still being studied.

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

About 222 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Feb 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 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: * Have recently quit smoking and are motivated to stay quit from smoking * Are reliable and willing to make themselves available for the duration of the study and attend required study visits and are willing and able to follow study procedures as required, such as self-inject study intervention Exclusion Criteria: * Have evidence of any substance use disorder within the past 180 days prior to screening, except mild alcohol use disorder, mild cannabis use disorder, or tobacco use disorder * Have answered "yes" to either Question 4 or Question 5 on the "Suicidal Ideation" portion of the C-SSRS and the ideation occurred within the past 6 months, or have answered "yes" to any of the suicide-related behaviors on the "Suicidal Behavior" portion of the C-SSRS and the behavior occurred within the past 6 months * Have severe chronic obstructive pulmonary disease, or any other clinically severe respiratory condition that in the investigator's opinion may pose a risk. * Have participated in a clinical study and have received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

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Conditions

The condition(s) this trial relates to.

Smoking

As listed by the trial registrant

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

Smoking

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 2nd Affiliated Hospital Chongqing Medical University

    RECRUITING

    Chongqing, 400072, China

  • Adams Clinical Dallas

    NOT_YET_RECRUITING

    DeSoto, Texas, 75115, United States

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63141, United States

  • Beijing Anding Hospital - Affiliated Capital University of Medical Science

    RECRUITING

    Beijing, 100088, China

  • Beijing Chaoyang Hospital, Capital Medical University

    RECRUITING

    Beijing, 100020, China

  • Circle Clinical Research

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Coastal Carolina Research Center

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Conquest Research - Orlando

    NOT_YET_RECRUITING

    Orlando, Florida, 32832, United States

  • Eastside Research Associates

    RECRUITING

    Redmond, Washington, 98052, United States

  • FutureSearch Trials of Dallas

    RECRUITING

    Dallas, Texas, 75251, United States

  • GTL Medical & Research Group

    RECRUITING

    Miami, Florida, 33173, United States

  • Health Research of Hampton Roads, Inc.

    RECRUITING

    Newport News, Virginia, 23606, United States

  • Higashi Shinjuku Clinic

    RECRUITING

    Tokyo, 169-0072, Japan

  • Hillcrest Medical Research

    COMPLETED

    DeLand, Florida, 32720, United States

  • K2 Medical Research ORLANDO

    RECRUITING

    Maitland, Florida, 32751, United States

  • Miyazaki RC Clinic

    RECRUITING

    Shinagawa-ku, 140-0001, Japan

  • North Georgia Clinical Research

    RECRUITING

    Woodstock, Georgia, 30189, United States

  • Revival Research Institute, LLC

    RECRUITING

    Dearborn, Michigan, 48126, United States

  • Rochester Clinical Research, LLC

    RECRUITING

    Rochester, New York, 14609, United States

  • Samoncho Clinic

    RECRUITING

    Shinjuku, 160-0017, Japan

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, 610072, China

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, 310016, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Linhai, 317000, China

  • TecTum Research

    RECRUITING

    Hollywood, Florida, 33024, United States

  • The University of Hong Kong-Shenzhen Hospital

    RECRUITING

    Shenzhen, 518053, China

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • The first affiliated hospital of Ningbo university

    RECRUITING

    Ningbo, 315010, China

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States

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