Health TrialsbyHealthPanel

A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse

ConditionSmoking
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: BrenipatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Number of Participants That Achieve CO-confirmed Continuous Abstinence from Cigarette Smoking Without Allowed Slips

Time frame
Week 1 to Week 24
2

Mean Change from Baseline in Patient Reported Outcomes

Time frame
Baseline, Week 24
3

Mean Percentage Change in Body Weight

Time frame
Baseline, Week 24
4

Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

Time frame
Baseline up to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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