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NCT Number: NCT07219173

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.

Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.

Recruiting

Interested in participating?

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro de Investigaciones Metabólicas (CINME), Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
  • Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
  • History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.

Exclusion criteria

  • Participants are excluded from the study if any of the following criteria apply:
  • An established diagnosis of occupational asthma
  • Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
  • chronic respiratory infection
  • bronchiectasis
  • pulmonary fibrosis
  • allergic bronchopulmonary aspergillosis
  • emphysema
  • chronic bronchitis
  • eosinophilic granulomatosis with polyangiitis
  • chronic obstructive pulmonary disease, and
  • other mimics of asthma, that is, vocal cord dysfunction.
  • Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.

Treatment and study plan

Brenipatide

Drug

Administered SC

Other names: LY3537031

Placebo

Drug

Administered SC

Primary outcomes

  1. Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment

    Time frame: Baseline to Week 52

    To assess the asthma exacerbation rate.

Secondary outcomes

  1. Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline, Week 52

  2. Change from Baseline in Patient Reported Health Outcomes

    Time frame: Baseline, Week 52

  3. Time to First Exacerbation

    Time frame: Baseline to Week 52

  4. Change from Baseline in Weekly Mean Rescue Medication Use

    Time frame: Baseline, Week 52

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

    Time frame: Baseline up to Week 52

  6. Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)

    Time frame: Baseline to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma

Acronym: RENEW-Asthma

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 21, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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