A Phase 2 interventional study of Brenipatide and Placebo in Smoking, sponsored by Eli Lilly and Company. Recruiting at 29 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 222 is above the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brenipatide administered subcutaneously (SC).
Drug: Brenipatide
Placebo administered SC.
Drug: Placebo
Administered SC
Also known as: LY3537031
Administered SC
Percentage of Participants that Achieve Carbon Monoxide (CO)-Confirmed Continuous Abstinence from Cigarette Smoking with Allowed Slips
Time frame: Week 1 to Week 24
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
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Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Nov 2025 (actual). Primary completion is estimated for Feb 2027, 15 months after the start.
Of 22 phase 2 interventional studies under Smoking, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 62. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Brenipatide