DelfaGLP-1 Atlas

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RecruitingPhase 1, PHASE2

A Study to Evaluate ALN-2232 in Participants With Obesity

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

156

estimated

Study population

Obesity / overweight

Key I/E criteria

•BMI 30-40•HbA1c ≤6.5%

Primary endpoints

•Treatment-emergent AEs (any)•Body weight, % change

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 IDNCT07463846
Org study IDALN-2232-001

Timeline

Milestones

Study start2026-03-02actual
Study first posted2026-03-11actual
Last update posted2026-05-14actual
Primary completion2027-04-27estimated
Study completion2028-03-02estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

All Parts:

•Has a body mass index (BMI) of ≥30 kg/m^2 and <40 kg/m^2
•Has a hemoglobin A1c (HbA1c) <6.5%

Exclusion criteria

All Parts:

•Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results
•Receiving therapies for chronic weight management or antidiabetic medications

Note: other protocol defined inclusion/exclusion criteria apply

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.

Coverage by outcome category

Safety / tolerability / PK
6
Weight & body composition
5
Other (unclassified)
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Part B: Percent Change from Baseline in Body Weight

Time frame:Baseline up to Month 6

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Part C: Percent Change from Baseline in Body Weight

Time frame:Baseline up to Month 6

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Part A: Percent Change from Baseline in Body Weight

Time frame:Baseline up to Month 12

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Part B and Part C: Percent Change from Baseline in Body Weight

Time frame:Baseline up to Month 12

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass

Time frame:Baseline up to Month 12

Total fat mass

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Primary/protocol endpoint

Part A: Frequency of Adverse Events (AEs)

Time frame:Up to 12 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma

Time frame:Predose and up to 15 days postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma

Time frame:Predose and up to 15 days postdose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma

Time frame:Predose and up to 15 days postdose

Tmax

descriptive

Secondary/protocol endpoint

Part A: Fraction of ALN-2232 excreted in urine

Time frame:Predose and up to 8 days postdose (fe)

descriptive

Secondary/protocol endpoint

Part B and Part C: Concentrations of ALN-2232 in Plasma

Time frame:Predose and up to 6 months postdose

Plasma concentration (steady state)

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Part A: Change from Baseline in Proteins in Adipose Tissue

Time frame:Baseline up to Month 12

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.