DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07654361

Not yet recruitingPhase 3

Efficacy and Safety of Aleniglipron in Participants With Obesity or Overweight With a Weight-Related Comorbidity (ACCOMPLISH-1)

A Randomized, Double-Blind, Placebo-Controlled, Pivotal Phase 3 Study to Evaluate the Long-Term Efficacy and Safety of Multiple Maintenance Doses of Once Daily Oral Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and a Weight-Related Comorbidity

Asset

Aleniglipron / GSBR-1290

Oral · GLP-1 agonist

Listed sites

71

Recruiting sites

—

Enrollment

3,600

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

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 IDNCT07654361
Org study IDGSBR-1290-12

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 / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age79 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Signed informed consent
•BMI ≥30 kg/m2 (obese) or BMI ≥27 kg/m2 (overweight) and presence of ≥1 of the obesity related comorbidities.

Exclusion criteria

•Previously documented diagnosis of type 1 diabetes, type 2 diabetes, or any other type of diabetes.
•Self-reported change in body weight >5 kg within 3 months before Screening.
•Have prior or planned surgical or non-surgical treatment for obesity.
•Have or plan to have endoscopic and/or device-based therapy for obesity.
•Have obesity induced by other endocrine disorders.
•Impaired renal function at Screening
•Chronic malabsorption

Endpoints (16)

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
10
Cardiometabolic biomarkers
4
Glycemic / diabetes
2

Weight & body composition

10 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

Percentage of participants who achieve ≥20% 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

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version physical function from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Secondary/protocol endpoint

Change in body mass index from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Other/protocol endpoint

Percentage of participants who achieve ≥25% reduction in body weight

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

Change in fasting glucose from Baseline

Time frame:Baseline and week 76

change from baseline, improvement

Cardiometabolic biomarkers

4 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

Secondary/protocol endpoint

Percent change in fasting total cholesterol from Baseline

Time frame:Baseline and week 76

percent change from baseline, improvement

Secondary/protocol endpoint

Change in resting diastolic blood pressure from Baseline

Time frame:Baseline and week 76

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.