DelfaGLP-1 Atlas

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Not yet recruitingPhase 3

A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

74

Recruiting sites

—

Enrollment

1,100

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c ≥6.5%

Primary endpoint

•Body weight

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 IDNCT07654374
Org study IDGSBR-1290-15

Timeline

Milestones

Study first posted2026-06-17actual
Last update posted2026-06-22actual
Study start2026-07estimated (month precision)
Primary completion2028-09estimated (month precision)
Study completion2028-11estimated (month precision)

Assets

Investigational agents

Aleniglipron / GSBR-1290

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age79 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Signed Informed Consent
•Have a BMI ≥27.0 kg/m2 at Screening
•Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol/mol) to ≤10% (86 mmol/mol) at Screening

Exclusion criteria

•Have type 1 diabetes, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
•Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.
•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
•Self-reported change in body weight >5 kg (11 pounds) within 3 months before Screening.
•Have prior or planned surgical or non-surgical treatment for obesity.

Endpoints (10)

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

Weight & body composition
6
Glycemic / diabetes
2
Cardiometabolic biomarkers
2

Weight & body composition

6 endpoints
Primary/protocol endpoint

Percent change in body weight from Baseline

Time frame:Baseline and week 76

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight (absolute) from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥5% reduction in body weight

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥10% reduction in body weight

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve ≥15% reduction in body weight

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in HbA1c from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants achieving HbA1c target value of ≤6.5%

Time frame:Baseline and week 76

threshold achievement, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in resting systolic blood pressure from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Percent change in fasting triglycerides and non-HDL cholesterol from Baseline

Time frame:Baseline and week 76

percent change from baseline, improvement

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.