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

NCT03350191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-04-25

No results posted yet for this study

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.
* 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.

Conditions

Interventions

DRUG

SAR425899

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

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

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

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

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

Sponsors & Collaborators

  • Antaros Medical

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-20
Primary Completion
2018-06-07
Completion
2018-06-07

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350191 on ClinicalTrials.gov