GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 1, PHASE2

A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus

A Phase 1/2A Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARO-ALK7 in Adult Volunteers With Obesity With and Without Type 2 Diabetes Mellitus

Lead sponsor

Arrowhead Pharmaceuticals

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

138

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 30-50

Primary endpoint

•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06937203

Org study IDAROALK7-1001

Timeline

Milestones

Study first posted2025-04-22actual

Study start2025-05-09actual

Last update posted2026-04-13actual

Primary completion2026-10estimated (month precision)

Study completion2026-10estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Obesity, defined as BMI between 30-50 kg/m2, inclusive, with weight at Screening not to exceed 159 kg (350 lbs)

•At least one self-reported, unsuccessful attempt at weight loss with lifestyle modification

•No abnormal finding of clinical relevance at Screening that could adversely impact participant safety during the study or adversely impact study results

•Participants of childbearing potential must agree to use highly effective contraception during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later. Participants must not donate sperm or eggs during the study for at least 90 days following the end of the study or last dose of study drug, whichever is later

Exclusion criteria

•Self-reported (or documented) weight gain or loss >5% within 3 months prior to Screening

•Use of GLP-1RAs (liraglutide, semaglutide, etc.) for any indication within 6 months prior to Screening

•Use of non-GLP-1R medications for weight loss within 3 months prior to Screening including but not limited to naltrexone/bupropion, orlistat, phentermine/topiramate and other prescription or over-the-counter medication or supplement taken for weight loss purposes

•Obesity attributable primarily in the Investigator's opinion to medication use, monogenic or endocrinologic disorders (other than polycystic ovary syndrome)

•History of prior surgical or device-based therapy for obesity (including endoscopic bariatric procedures)

•Use of medications or therapies strongly associated with weight gain, alterations in body composition, or increase in muscle mass, within 3 months prior to Screening

•Type 1 diabetes mellitus

Note: Additional inclusion/exclusion criteria may apply per protocol

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

12 endpoints

Primary/protocol endpoint

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

Time frame:Up to Day 253 End of Study (EOS)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK) of ARO-ALK7 (Part 1 Only): Maximum Observed Plasma Concentration (Cmax)