A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brenipatide, Placebo.
- Who it may be relevant to
- Registry conditions: Smoking. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China, Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2, Multicenter, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for Reduction in Risk of Relapse to Cigarette Smoking in Adults (RENEW-Smk-1)
Overview
This study evaluates the efficacy and safety of brenipatide when compared to placebo for reducing the risk of relapse to cigarette smoking in adults who have recently quit. Study participation will last approximately 34 weeks with up to 17 study visits, which includes a 2-week screening period, 24-week treatment period, 8-week safety follow-up period.
Interventions
- Drug Brenipatide
Administered SC - Drug Placebo
Administered SC
Primary outcome measures
- Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips [Time frame: Week 1 to Week 24]
Secondary outcome measures (5)
- Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips [Time frame: Week 1 to Week 24]
- Mean Change from Baseline in Patient Reported Outcomes [Time frame: Baseline, Week 24]
- Mean Percentage Change in Body Weight [Time frame: Baseline, Week 24]
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Baseline up to Week 24]
- Number of Treatment-emergent Anit-drug Antibodies [Time frame: Baseline up to Week 24]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 17 centers
- Woodland Research Northwest — Rogers
- Hillcrest Medical Research — DeLand
- TecTum Research — Hollywood
- K2 Medical Research ORLANDO — Maitland
- GTL Medical & Research Group — Miami
- North Georgia Clinical Research — Woodstock
- Revival Research Institute, LLC — Dearborn
- Arch Clinical Trials — St Louis
- … and 9 more centers
China · 8 centers
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
- Beijing Anding Hospital - Affiliated Capital University of Medical Science — Beijing
- Sichuan Provincial People's Hospital — Chengdu
- 2nd Affiliated Hospital Chongqing Medical University — Chongqing
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine — Hangzhou
- Taizhou Hospital of Zhejiang Province — Linhai
- The first affiliated hospital of Ningbo university — Ningbo
- The University of Hong Kong-Shenzhen Hospital — Shenzhen
Japan · 3 centers
- Miyazaki RC Clinic — Shinagawa-ku
- Samoncho Clinic — Shinjuku
- Higashi Shinjuku Clinic — Tokyo
Identifiers
NCT: NCT07223840 · 27411 · J2S-MC-GZMO