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LY3537031

Clinical trials are investigating LY3537031 in adults with alcohol use disorder and uncontrolled moderate to severe asthma. These studies aim to check whether the treatment works better than placebo and to measure safety, response, and longer-term effects in different patient groups.

Table of contents

Clinical trials overview

Current studies of LY3537031 are testing it in two different conditions: alcohol use disorder and uncontrolled moderate to severe asthma.[1][2][3] These are interventional studies, which means researchers give a study treatment and compare results with placebo.[1][2][3]

All three trials are listed as Authorised.[1][2][3] Two studies are in Phase 3, and one study is in Phase 2.[1][2][3]

Alcohol use disorder studies

Two Phase 3 trials are studying LY3537031 in people with alcohol use disorder, including one study in participants with moderate-to-severe alcohol use disorder.[1][2] The planned enrollment is 949 participants in one study and 1,090 participants in the other.[1][2]

The main goal in both alcohol studies is to show that at least one dose level is better than placebo for at least one of the dual primary endpoints.[1][2] In simple terms, this means the researchers want to see whether LY3537031 helps people do better than placebo on the main results the study is designed to measure.[1][2]

These studies also include a second period for responders, meaning people who improved in Period 1.[1][2] In Period 2, the trial checks whether LY3537031 can help maintain a general reduction in alcohol consumption over time.[1][2]

One alcohol study lists the primary outcome as behaviors associated with alcohol use disorder, measured by the Timeline Followback Method (TLFB).[2] TLFB is a structured way to track drinking behavior over a set period.[2]

Asthma study

One Phase 2 trial is studying LY3537031 in adult participants with uncontrolled moderate to severe asthma.[3] The study plans to enroll 538 participants.[3]

The main purpose of this trial is to compare LY3537031 with placebo and see whether it reduces severe asthma exacerbations.[3] An asthma exacerbation is a worsening of asthma symptoms, often called a flare-up or attack.[3]

The primary outcome is the annualized asthma exacerbation rate over 52 weeks of treatment, measured from baseline to Week 52.[3] This means the study counts how often severe asthma flare-ups happen during the treatment period.[3]

Main endpoints and what they mean

A primary endpoint is the main result a clinical trial uses to decide whether the treatment is working.[1][2][3] In the alcohol studies, the endpoints focus on alcohol-related behavior and reduced alcohol consumption.[1][2]

In the asthma study, the main endpoint is the rate of severe flare-ups during one year of treatment.[3] This helps researchers understand whether the study treatment can lower the number of asthma worsening events over time.[3]

Who may take part

The alcohol use disorder trials are for participants with alcohol use disorder, and one of them specifically names moderate-to-severe alcohol use disorder.[1][2] The asthma trial is for adult participants with uncontrolled moderate to severe asthma.[3]

Each study has its own entry rules, but the trial records show the main target groups clearly.[1][2][3] The studies are designed for people who have the condition being tested, not for the general population.[1][2][3]

Trial design and study status

All three studies are interventional and compare LY3537031 with placebo.[1][2][3] The alcohol studies use a multi-period design, with an early period to test response and a later period to see whether benefits last in responders.[1][2]

The asthma study follows participants for 52 weeks, which gives researchers a longer view of asthma control during treatment.[3] All studies are currently marked as authorised, which means they have been approved to move forward in the trial process.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
2025-522312-16-00 Phase 3 Alcohol use disorder Authorised 949
2025-522313-38-00 Phase 3 Moderate-to-severe alcohol use disorder Authorised 1,090
2025-522640-41-00 Phase 2 Uncontrolled moderate to severe asthma Authorised 538

FAQ

  • What conditions are being studied in LY3537031 trials? The trials are studying alcohol use disorder and uncontrolled moderate to severe asthma. They look at whether LY3537031 can improve alcohol-related outcomes or reduce asthma flare-ups.
  • Who can take part in these studies? One trial includes participants with moderate-to-severe alcohol use disorder, and another includes adult participants with uncontrolled moderate to severe asthma. Each study has its own rules for who can join.
  • What phases are the LY3537031 trials? The alcohol use disorder studies are Phase 3 trials. The asthma study is a Phase 2 trial.
  • What are the trials trying to measure? The alcohol use disorder studies measure alcohol-related behaviors and reduction in alcohol consumption. The asthma study measures the annualized asthma exacerbation rate, which means how often asthma attacks happen over time.
  • How many participants are planned across these trials? The planned enrollment is 949 participants in one alcohol use disorder study, 1,090 in another alcohol use disorder study, and 538 in the asthma study.

Ongoing Clinical Trials on LY3537031

  • A Study of Brenipatide Compared to Placebo for Adults with Uncontrolled Moderate to Severe Asthma

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Germany The Netherlands Poland

Glossary

  • Alcohol use disorder (AUD): A medical condition where a person has trouble controlling alcohol use, even when it causes problems.
  • Moderate-to-severe: A level of illness that is more than mild and may need close treatment or study.
  • Asthma exacerbation: A worsening of asthma symptoms, often called an asthma attack or flare-up.
  • Annualized asthma exacerbation rate: The number of asthma flare-ups measured over a year.
  • Placebo: A treatment that looks like the study drug but does not contain the active study medicine.
  • Phase 2: An earlier clinical trial phase that mainly looks at whether a treatment works and how safe it is.
  • Phase 3: A later clinical trial phase that compares a treatment with placebo or standard care in larger groups.
  • Interventional study: A study where researchers give a treatment to see what effect it has.
  • Primary outcome: The main result a study is designed to measure.
  • Timeline Followback Method (TLFB): A way to track alcohol use by asking participants to recall their drinking over a set time.
  • Responder: A participant who improves enough in the study to be counted as having a response.

References

  1. https://clinicaltrials.gov/study/2025-522312-16-00
  2. https://clinicaltrials.gov/study/2025-522313-38-00
  3. https://clinicaltrials.gov/study/2025-522640-41-00