Brenipatide
updated
Brenipatide is Lilly’s investigational LY3537031, a 39-amino-acid dual GIP and GLP-1 receptor agonist. ClinicalTrials.gov listed 18 code-linked records; none had posted results.
Dual GIP and GLP-1 receptor agonist peptide
- Modified 39-amino-acid peptide
- Also indexed as LY3537031
- Studied mainly by subcutaneous injection
- No posted results in the cited trial records
What is brenipatide, and why do some records say LY3537031?
Brenipatide is the international nonproprietary name for Lilly's LY3537031. WHO describes it as a modified 39-amino-acid agonist at both the GIP and GLP-1 receptors. ClinicalTrials.gov records under either name belong to the same development program.
Five earlier ClinicalTrials.gov records use LY3537031 without the brenipatide name. Thirteen newer records are indexed under brenipatide and also include the code.
WHO INN · identity and receptor class
WHO nomenclature document
World Health Organization, WHO Drug Information, 2025
The INN entry names brenipatide and classifies it as a GIP and GLP-1 receptor agonist. Its chemical description contains 39 amino-acid residues with a modified side chain.
- The INN confirms identity and intended pharmacology; it contains no clinical efficacy result.
- Participants / model
- Drug nomenclature record
- Treatment
- Brenipatide
- Follow-up
- Proposed INN list published 2025
- Study design
- International nonproprietary name document
An INN is a standardized name, not a drug approval.
Read the original sourceClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceIs brenipatide an approved medicine?
The cited FDA records list no approval or prescribing label for brenipatide or LY3537031. It remains an investigational drug used in registered studies.
A WHO name, a ClinicalTrials.gov entry, and a phase 3 designation describe development status. They do not authorize a drug for sale.
FDA records · no approved entry
Regulatory database record set
Drugs@FDA and FDA label records
The cited U.S. approval and label records contain no approved drug or prescribing label under brenipatide or LY3537031.
- Participants / model
- United States marketing authorizations
- Treatment
- Brenipatide; LY3537031
- Study design
- Exact-name and development-code U.S. approval coverage
What does the current trial registry actually show?
The cited ClinicalTrials.gov records list 18 studies under the exact LY3537031 intervention name: 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two were active but not recruiting, eleven were recruiting, and two were not yet recruiting. None of the 18 cited trial records included posted results.
| Registry state | Records | Meaning |
|---|---|---|
| Completed | 3 | The registered study ended; no result was posted |
| Active, not recruiting | 2 | Follow-up or study activity may continue |
| Recruiting | 11 | Enrollment was open in the registry |
| Not yet recruiting | 2 | The study was planned, without an outcome |
Counts deduplicate the brenipatide and LY3537031 names by NCT identifier.
ClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceWhy does one drug appear in so many unrelated programs?
The registered program tests separate hypotheses in obesity, substance-use disorders, psychiatric disorders, asthma, chronic obstructive pulmonary disease, and irritable bowel syndrome. Results in one population cannot answer whether the drug works in another.
| Program area | Registered studies |
|---|---|
| Phase 1 and pharmacology | Healthy volunteers; overweight or obesity; hepatic impairment; renal impairment; absorption and bioavailability |
| Substance use | Two alcohol-use phase 3 trials; phase 2 smoking-relapse and opioid-use trials |
| Psychiatry | Bipolar disorder and schizophrenia phase 2; two major-depression phase 3 trials |
| Respiratory | Asthma and COPD phase 2 |
| Gastrointestinal | IBS with diarrhea and IBS with constipation phase 2 |
The cited trial records contain no posted results.
ClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceDo the three completed phase 1 studies establish a safety profile?
The three completed records cover an early healthy-participant study, a renal-impairment pharmacokinetic study, and an absorption study. None posts adverse-event results, exposure tables, or a general contraindication list.
Completed is an administrative study status. Without posted results, it does not show how often adverse events occurred, whether any serious event was related to treatment, or which dose was tolerated.
ClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceHas brenipatide shown weight loss in people?
Two phase 1 records include participants with overweight or obesity, but neither provides a public brenipatide-specific weight-loss result. Registry status and enrollment alone cannot supply an efficacy estimate.
The current obesity study is active but not recruiting, has an estimated enrollment of 150, and has no posted results. It cannot support a percentage weight-loss claim or comparison with another drug.
NCT07476118 · obesity phase 1
Clinical trial registry record
ClinicalTrials.gov, NCT07476118
The phase 1 subcutaneous study lists 150 estimated participants, active but not recruiting status, and no posted results.
- Participants / model
- Healthy adults with overweight or obesity
- Treatment
- Subcutaneous brenipatide or placebo under a research protocol
- Follow-up
- Estimated completion February 2027 in the cited record
- Study design
- Randomized phase 1 study
- Funding
- Eli Lilly and Company
The registry gives no public weight-loss estimate.
Read the original sourceClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceDoes dual GIP and GLP-1 receptor agonism predict the clinical result?
Dual GIP and GLP-1 receptor activity identifies the drug's intended targets. It does not predict the size or direction of its effects in obesity, addiction, psychiatric, respiratory, or gastrointestinal trials.
Results from another dual agonist cannot be copied to brenipatide. Sequence, exposure, receptor activity, dose schedule, population, and endpoint all matter.
WHO INN · identity and receptor class
WHO nomenclature document
World Health Organization, WHO Drug Information, 2025
The INN entry names brenipatide and classifies it as a GIP and GLP-1 receptor agonist. Its chemical description contains 39 amino-acid residues with a modified side chain.
- The INN confirms identity and intended pharmacology; it contains no clinical efficacy result.
- Participants / model
- Drug nomenclature record
- Treatment
- Brenipatide
- Follow-up
- Proposed INN list published 2025
- Study design
- International nonproprietary name document
An INN is a standardized name, not a drug approval.
Read the original sourceClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceWhat can be said about dosing, interactions, and adverse effects?
There is no public prescribing label or posted brenipatide adverse-event dataset. The cited records do not establish a routine dose, titration schedule, missed-dose rule, contraindication list, pregnancy guidance, or interaction profile.
ClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceFDA records · no approved entry
Regulatory database record set
Drugs@FDA and FDA label records
The cited U.S. approval and label records contain no approved drug or prescribing label under brenipatide or LY3537031.
- Participants / model
- United States marketing authorizations
- Treatment
- Brenipatide; LY3537031
- Study design
- Exact-name and development-code U.S. approval coverage
Studies and sources
WHO INN · identity and receptor class
WHO nomenclature document
World Health Organization, WHO Drug Information, 2025
The INN entry names brenipatide and classifies it as a GIP and GLP-1 receptor agonist. Its chemical description contains 39 amino-acid residues with a modified side chain.
- The INN confirms identity and intended pharmacology; it contains no clinical efficacy result.
- Participants / model
- Drug nomenclature record
- Treatment
- Brenipatide
- Follow-up
- Proposed INN list published 2025
- Study design
- International nonproprietary name document
An INN is a standardized name, not a drug approval.
Read the original sourceClinicalTrials.gov · 18 deduplicated records
Registry record set
ClinicalTrials.gov records
ClinicalTrials.gov listed 18 unique NCT records under LY3537031 and a 13-record subset under brenipatide. Phase counts were 6 phase 1, 8 phase 2, and 4 phase 3. Three were completed, two active not recruiting, eleven recruiting, and two not yet recruiting. None had posted results.
- Counts represent unique NCT identifiers across both aliases.
- Five records use only the development code, so the brenipatide name covers 13 of 18 records.
- Participants / model
- All ClinicalTrials.gov records indexed to the exact intervention aliases
- Treatment
- Brenipatide or LY3537031
- Study design
- Exact-intervention registry records grouped by NCT identifier
- Funding
- Study records list Eli Lilly and Company as sponsor
Registry status, phase, and enrollment are not efficacy or safety outcomes.
Read the original sourceNCT07476118 · obesity phase 1
Clinical trial registry record
ClinicalTrials.gov, NCT07476118
The phase 1 subcutaneous study lists 150 estimated participants, active but not recruiting status, and no posted results.
- Participants / model
- Healthy adults with overweight or obesity
- Treatment
- Subcutaneous brenipatide or placebo under a research protocol
- Follow-up
- Estimated completion February 2027 in the cited record
- Study design
- Randomized phase 1 study
- Funding
- Eli Lilly and Company
The registry gives no public weight-loss estimate.
Read the original sourceFDA records · no approved entry
Regulatory database record set
Drugs@FDA and FDA label records
The cited U.S. approval and label records contain no approved drug or prescribing label under brenipatide or LY3537031.
- Participants / model
- United States marketing authorizations
- Treatment
- Brenipatide; LY3537031
- Study design
- Exact-name and development-code U.S. approval coverage
Why is Brenipatide in C tier?
C tier recognizes a defined molecule and 18 registered human studies. None of those records had posted results, so efficacy, adverse-event rates, contraindications, interactions, and routine dosing remain unknown.