DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02411825

CompletedPhase 1

Multiple Ascending Dose Study in Healthy Male Subjects and Overweight to Obese Male and Female Type 2 Diabetes Mellitus (T2DM) Patients

A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneous Doses of SAR425899 in Healthy Male Subjects and Overweight to Obese Patients With Type 2 Diabetes Mellitus

Lead sponsor

Sanofi

Asset

SAR425899

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

76

actual

Study population

Healthy volunteers, Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 20-30•HbA1c 6.5-8.5%•Healthy volunteers

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 IDNCT02411825
Org study IDTDR13700
Secondary ID2014-004216-10
Secondary IDU1111-1163-1209UTN

Timeline

Milestones

Study first posted2015-04-08estimated
Last update posted2018-06-15actual
Study start2015-03 (month precision)
Primary completion2016-01actual (month precision)
Study completion2016-01actual (month precision)

Assets

Investigational agents

SAR425899

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

Healthy subjects:

•Males, between 18 and 55 years of age, inclusive.
•Body mass index (BMI) between 20.0 and 30.0 kg/m^2, inclusive; body weight between 50.0 and 120.0 kg, inclusive.
•Certified as healthy by comprehensive clinical assessment (detailed medical history, complete physical examination). Comorbidities of higher weight (eg, mild impaired glucose tolerance, mild hypertension, mild hyperlipidemia) are permitted unless, per investigator, these conditions hamper participation.
•Normal vital signs after 10 minutes resting supine:
•95 mmHg <systolic blood pressure (SBP) <150 mmHg.
•45 mmHg <diastolic blood pressure (DBP) <100 mmHg.
•50 bpm <heart rate (HR) <100 bpm.
•Standard 12-lead electrocardiogram (ECG) parameters after 10 minutes resting in supine position within; 120 ms <PR <220 ms, QRS <120 ms, QTc ≤430 ms, normal ECG.
•Normal 24-hour Holter electrocardiography at screening.
•Laboratory parameters within normal range; however serum creatinine, alkaline phosphatase, hepatic enzymes (aspartate aminotransferase, alanine aminotransferase), and total bilirubin (unless subject has Gilbert syndrome) should not exceed upper laboratory norm (ULN).

T2DM patients:

•Males and females, 18-70 years of age.
•Body weight 50.0-150.0 kg, BMI 28.0 - 42.0 kg/m^2.
•Diagnosis of T2DM for at least 1 year with stable metformin prior to inclusion; comorbidities related to T2DM but otherwise healthy.
•Normal vital signs supine:
•95 mmHg < SBP <160 mmHg
•45 mmHg < DBP <100 mmHg
•50 bpm < HR <100 bpm
•Normal standard 12-lead ECG in supine position unless abnormality is clinically irrelevant.
•Laboratory parameters in normal range unless abnormality is clinically irrelevant or strongly associated with T2DM; total bilirubin not to exceed ULN.
•Fasting plasma glucose ≥90 mg/dL.
•HbA1c ≥6.5% and ≤8.5%.
•Females: Sterilization at least 3 months before inclusion or postmenopausal.

Both:

•Signed written informed consent.
•Not supervised/confined for legal or administrative reasons.
•Male subject with partner of childbearing potential (including lactating women) must use double contraception method.
•Male subject with pregnant partner must use a condom up to 2 months after last dosing.
•Male subject agreed not to donate sperm up to 2 months after last dosing.
•Not undergoing physical training program/planning changes in activity; not vegetarian or following special diet.

Exclusion criteria

Healthy subjects:

•History of clinically relevant disease/signs of acute illness.
•History of drug hypersensitivity/allergic disease.
•Smoking more than 5 cigarettes/day.
•Any medication within 14 days before inclusion or within 5 times elimination/pharmacodynamic half-life of the medication and during study; vaccination within last 28 days, biologics given within 4 months before inclusion.

T2DM patients:

•History/presence of clinically relevant disease/signs of acute illness not related to patient's metabolic status.
•History/presence of drug hypersensitivity or allergic disease.
•Smoking more than 5 cigarettes per day.
•If female, pregnancy/breast-feeding.
•Any intake of medication during treatment period and within 21 days before first dosing or within 5 times half-life of the medication, except: metformin, standard antihypertensive treatment, statins, acetyl salicylic acid.
•Thyroid hormone replacement is allowed if dose was stable for 3 months prior to screening.
•Individual background therapy, considered necessary for the patient's welfare, that could not be discontinued for the duration of the study, may be given at the discretion of the Investigator, with a stable dose (when possible) and only if its intake is unlikely to interfere with the investigational product.
•Treated with sulphonyl-ureas up to 3 months, proton pump inhibitors up to 1 week prior to dosing.
•Vaccination within last 28 days, any biologics within 4 months before inclusion.
•Severe hypoglycemia resulting in seizure/unconsciousness/coma/hospitalization for diabetic ketoacidosis in last 3 months before screening.
•Persistent hyperglycemia not controlled by metformin/diet/exercise.
•Diabetic neuropathy, retinopathy, nephropathy or renal impairment.
•Hepatic impairment.
•Unstable hypo- or hyperthyroidism.

Both:

•Headaches/migraine.
•Recurrent nausea/vomiting.
•Blood donation within 1 month before inclusion.
•Symptomatic postural hypotension, irrespective of decrease in BP, or asymptomatic postural hypotension defined as decrease in SBP ≥20 mmHg within 3 minutes when changing from supine to standing.
•History/presence of drug or alcohol abuse.
•Positive result: hepatitis B surface antigen, anti-hepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
•Any condition affecting gastric emptying or absorption from GI tract.
•Surgically treated obesity, bariatric surgery.
•Severe dyslipidemia with fasting triglycerides >450 mg/dL.
•History of pancreatitis or pancreatectomy.
•Amylase/lipase >3 ULN.
•History of thyroid cancer or a genetic condition that predisposes to thyroid cancer.
•Elevated basal calcitonin.

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

Endpoints (21)

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
12
Glycemic / diabetes
5
Other (unclassified)
2
Weight & body composition
1
Cardiometabolic biomarkers
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from baseline in Body weight

Time frame:28 to 35 days

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Change from baseline in Fasting Blood Glucose

Time frame:28 to 35 days

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in Postprandial Blood Glucose

Time frame:28 to 35 days

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in postprandial Insulin

Time frame:28 to 35 days

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in postprandial C-peptide profiles

Time frame:28 to 35 days

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in HbA1c

Time frame:28 to 35 days

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint/low confidence

Change from baseline in biomarkers (lipid biomarker)

Time frame:28 to 35 days

change from baseline, improvement

Safety / tolerability / PK

12 endpoints
Primary/protocol endpoint

Number of adverse events

Time frame:28 to 35 days

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint/low confidence

Changes in vital signs

Time frame:28 to 35 days

change from baseline, descriptive

Secondary/protocol endpoint

Changes in physical examination

Time frame:28 to 35 days

descriptive

Secondary/protocol endpoint

Changes in ECG

Time frame:28 to 35 days

change from baseline, descriptive

Secondary/protocol endpoint

Changes in clinical laboratory parameters (hematology)

Time frame:28 to 35 days

descriptive

Secondary/protocol endpoint

Changes in clinical laboratory parameters (biochemistry)

Time frame:28 to 35 days

change from baseline, descriptive

Secondary/protocol endpoint

Changes in body temperature

Time frame:28 to 35 days

change from baseline, descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic parameters in blood (AUC)

Time frame:28 to 35 days

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic parameters in blood (Cmax)

Time frame:28 to 35 days

Cmax

concentration, descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic parameters in blood (t1/2)

Time frame:28 to 35 days

Half-life

descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic parameters in urine (Ae0-24)

Time frame:28 to 35 days

descriptive

Secondary/protocol endpoint

Assessment of pharmacokinetic parameters in urine (fe0-24)

Time frame:28 to 35 days

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Change from baseline in biomarkers (FGF21)

Time frame:28 to 35 days

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from baseline in biomarkers (incretins)

Time frame:28 to 35 days

change from baseline, descriptive

Publications (2)

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.