DelfaGLP-1 Atlas

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CompletedPhase 1

A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients

A PET/CT Study to Assess the Receptor Occupancy by SAR425899 After Repeat Dosing Using Radiolabelled Tracers for the Glucagon and GLP-1 Receptor in Overweight to Obese T2DM Patients

Lead sponsor

Sanofi

Assets

Exenatide / SAR425899

Listed sites

1

Recruiting sites

—

Enrollment

13

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 28-38•HbA1c 6.5-9%

Primary endpoint

•Glucagon receptor occupancy

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 IDNCT03350191
Org study IDPDY15264
Secondary ID2017-001789-23

Timeline

Milestones

Study first posted2017-11-22actual
Study start2017-12-20actual
Primary completion2018-06-07actual
Study completion2018-06-07actual
Last update posted2022-04-25actual

Assets

Investigational agents

ExenatideSAR425899

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male and female patients, between 18 and 75 years of age, inclusive.
•Body weight between 60.0 and 120.0 kg, inclusive, body mass index between 28.0 and 38.0 kg/m2, inclusive.
•Diagnosis of type 2 diabetes mellitus for at least 1 year at the time of inclusion with stable metformin treatment prior to inclusion, with or without comorbidities related to type 2 diabetes mellitus.
•Fasting plasma glucose ≥ 90 mg/dL at screening.
•Glycosylated hemoglobin (HbA1c) ≥6.5% and ≤9 % at screening.

Exclusion criteria

•Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecologic (if female), urologic or infectious disease, hormonal active tumors (e.g. pheochromocytoma or insulinoma), or signs of acute illness that is not related to the metabolic status of the patient.
•Presence or history of drug hypersensitivity (including known allergic reactions associated with glucagon like peptide-1 (GLP-1) agonist treatment [exenatide, liraglutide, lixisenatide]), or allergic disease diagnosed and treated by a physician.
•Any intake of menopausal hormone replacement therapy, systemic corticosteroids, growth hormones, weight-loss drugs, antihyperlipidemic treatment, antihyperglycemic treatment [e.g., GLP-1 agonists, insulin, thiazolidinediones, dipeptidylpeptidase (DPP-IV) inhibitors, sodium/glucose cotransporter-2 (SGLT-2) inhibitors etc.]) during the treatment period and within 21 days before first dosing or within 5 times the elimination half-life or pharmacodynamic half-life of the medication (if known), with the exception of metformin, sulphonylureas (SU), standard antihypertensive treatment, statins and acetyl salicylic acid.
•Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (e.g., gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy, hysterectomy, cholecystectomy and herniaplasty).
•Surgically treated obesity, bariatric surgery.
•Severe dyslipidemia with fasting triglycerides >450 mg/dL at screening.
•Severe hypoglycemia resulting in seizure/unconsciousness/coma or hospitalization for diabetic ketoacidosis in the last 3 months before screening.
•Persistent hyperglycemia not adequately controlled by metformin, SUs and/or diet/exercise.
•Diagnosed diabetic neuropathy, retinopathy, nephropathy or renal impairment (GFR <60 mL/min; estimate after Cockcroft-Gault) at screening.
•Unstable hypo- or hyperthyroidism (as assessed by TSH) at screening.
•History of pancreatitis or pancreatectomy.
•Amylase and/or lipase > 2 upper limit of normal (ULN) at screening.
•Personal history or family history of medullary thyroid cancer or a genetic condition that predisposes to medullary thyroid cancer.
•Elevated basal calcitonin (≥20 pg/mL / 5.9 pmol/L) at screening.
•Known past or present diseases or disorders of any target organ (liver, pancreas, spleen).
•Medical positron emitting tomography (PET), single photon emission computer tomography (SPECT), abdominal or thoracic computer tomography (CT) examination during the previous 12 months' time period.
•Claustrophobia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

Safety / tolerability / PK
6
Other (unclassified)
5
Cardiometabolic biomarkers
4
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in fasting plasma glucose (FPG)

Time frame:Day 1 to Day 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint/low confidence

Change in ketone bodies

Time frame:Day 1 to Day 20

change from baseline, improvement

Secondary/protocol endpoint

Change lipid biomarkers

Time frame:Day 1 to Day 20

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change lipid biomarkers

Time frame:Day 1 to Day 20

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change lipid biomarkers

Time frame:Day 1 to Day 20

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Adverse events

Time frame:Up to 27 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 20

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 20

Tmax

descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 20

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 20

Half-life

descriptive

Secondary/protocol endpoint

Pharmacokinetics

Time frame:Day 20

descriptive

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Glucagon receptor occupancy

Time frame:Day 1 and Day 20

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

GLP-1 receptor occupancy

Time frame:Day 1 and Day 17

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in volume of distribution (Vt) in the liver

Time frame:Day 1 and Day 20

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Vt in the pancreas

Time frame:Day 1 and Day 17

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Average standard uptake values (SUVs) of PET tracers in the liver and pancreas

Time frame:Day 1, Day 17 and Day 20

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.