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Type 2 Diabetes MellitusPhase 1NCT03350191

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

A Phase 1 study testing SAR425899, [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) and [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objectives: To assess in overweight to obese T2DM patients: The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a tracer compound. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
SAR425899, [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) and [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSweden
Study dates
20 Dec 2017to 7 Jun 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Investigational Site Number 7520001

    Uppsala, 75237

Other trials in Sweden

About this study

Official title: 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

Primary Objectives:

To assess in overweight to obese T2DM patients:

  • The glucagon receptor occupancy of SAR425899 at two dose levels in the human liver with positron-emission tomography (PET) imaging using [68Ga]Ga-DO3A-VS-Cys40-Tuna-2 as a tracer compound.
  • The GLP-1 receptor occupancy of SAR425899 at two dose levels in the human pancreas with PET imaging using [68Ga]Ga-DO3A-VS-Cys40-Exendin-4 as a tracer compound.
  • Pharmacodynamic effects on fasting plasma glucose and biomarkers of lipid metabolism.
  • Pharmacokinetic parameters for SAR425899 after repeated subcutaneous (SC) doses in plasma.
  • Safety and tolerability of SAR425899.
Read the detailed description

Study duration is approximately 7 weeks with a 20 days treatment period.

Being tested
SAR425899, [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer), [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR425899Drug

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer)Drug

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)Drug

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

Study groups in NCT03350191
Study groupRoleWhat they receive
SAR425899 high doseExperimentalRepeated once daily subcutaneous (SC) doses of SAR425899 administered over 20 days
Receives: Drug: SAR425899; Drug: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer); Drug: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)
SAR425899 low doseExperimentalRepeated once daily SC doses of SAR425899 administered over 20 days
Receives: Drug: SAR425899; Drug: [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer); Drug: [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glucagon receptor occupancy

    Change of glucagon receptor tracer binding in the liver with SAR425899 between Day 1 and Day 20

    Measured: Day 1 and Day 20

Secondary outcomes (15)

  1. GLP-1 receptor occupancy

    Change of GLP-1 receptor tracer binding in the pancreas with SAR425899 between Day 1 and Day 17

    Measured: Day 1 and Day 17

  2. Adverse events

    Number of adverse events in patients under treatment with SAR425899

    Measured: Up to 27 days

  3. Pharmacokinetics

    Assessment of SAR425899 maximum plasma concentration (Cmax)

    Measured: Day 20

  4. Change in fasting plasma glucose (FPG)

    Absolute change in FPG from baseline to Day 20

    Measured: Day 1 to Day 20

  5. Change in ketone bodies

    Absolute change in ketone bodies from baseline to Day 20

    Measured: Day 1 to Day 20

  6. Change lipid biomarkers

    Absolute change cholesterol from baseline to Day 20

    Measured: Day 1 to Day 20

  7. Change in volume of distribution (Vt) in the liver

    Change of glucagon receptor tracer Vt in the liver with SAR425899 between Day 1 and Day 20

    Measured: Day 1 and Day 20

  8. Change in Vt in the pancreas

    Change of GLP-1 receptor tracer Vt in the pancreas with SAR425899 between Day 1 and Day 17

    Measured: Day 1 and Day 17

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

    Average SUVs for glucagon and GLP-1 tracer in liver and pancreas

    Measured: Day 1, Day 17 and Day 20

  10. Pharmacokinetics

    Assessment of SAR425899 time to reach Cmax ( tmax)

    Measured: Day 20

  11. Pharmacokinetics

    Assessment of SAR425899 area under the concentration versus time curve (AUC)

    Measured: Day 20

  12. Pharmacokinetics

    Assessment of SAR425899 terminal elimination half-life ( t1/2)

    Measured: Day 20

  13. Pharmacokinetics

    Assessment of SAR425899 total body clearance from the plasma (CL)

    Measured: Day 20

  14. Change lipid biomarkers

    Absolute change in free fatty acids from baseline to Day 20

    Measured: Day 1 to Day 20

  15. Change lipid biomarkers

    Absolute change in triglycerides from baseline to Day 20

    Measured: Day 1 to Day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start20 Dec 2017
  3. Primary completion7 Jun 2018
  4. Study completion7 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350191
Sponsor's protocol ID
PDY15264
Other IDs
2017-001789-23, 2017
Status last verified
Apr 2022
First submitted
16 Nov 2017
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Eriksson O, Velikyan I, Haack T, Bossart M, Laitinen I, Larsen PJ, Berglund JE, Antoni G, Johansson L, Pierrou S, Tillner J, Wagner M. Glucagonlike Peptide-1 Receptor Imaging in Individuals with Type 2 Diabetes. J Nucl Med. 2022 May;63(5):794-800. doi: 10.2967/jnumed.121.262506. Epub 2021 Sep 9.

    PubMed 34503957

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SAR425899, [68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer) and [68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer) in people with Type 2 Diabetes Mellitus, run by Sanofi at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucagon receptor occupancy (time frame: Day 1 and Day 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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