A Study on Safety and Tolerability of SAR425899 in Overweight to Obese Subjects and Type 2 Diabetes Mellitus Patients Not Requiring Anti-Diabetic Pharmacotherapy With an Optional 6-month Safety Extension Period

NCT03414736 | Completed Phase 1 FDA Drug

• 2 other identifiers: TDR15516U1111-1205-1368
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

Primary Objectives:

• Main study: To assess in overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy the safety and tolerability of 3 different dose escalation regimens of SAR425899 in terms of the relative and absolute frequency and severity of gastrointestinal (GI) adverse events (AEs).
• Six-month safety extension period: To assess the safety and tolerability of SAR425899 after 6 months treatment at the maximum dose that was individually well tolerated during the main part of the study in terms of the relative and absolute frequency and severity of GI AEs. Secondary Objectives: Main study and 6-month study extension period: To assess in overweight to obese subjects and T2DM patients not requiring anti-diabetic pharmacotherapy:
• The effect of once-daily dosing of SAR425899 on body weight (BW), fasting plasma glucose (FPG), and hemoglobin A1c (HbA1c).
• Safety and tolerability.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Frequency of gastrointestinal (GI) adverse events (AEs)

  Relative frequency of GI AEs

  Main study: Up to week 8; Six-month study extension period: Up to month 8

• Frequency of GI AEs

  Absolute frequency of GI AEs

  Main study: Up to week 8; Six-month study extension period: Up to month 8

• Frequency of GI AEs

  Severity of GI AEs

  Main study: Up to week 8; Six-month study extension period: Up to month 8

Secondary Outcomes (4)

• Change in body weight

  Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

• Change in fasting plasma glucose (FPG)

  Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

• Change in hemoglobin A1c (HbA1c)

  Main study: Baseline (D1) to week 8; Six-month study extension period: Baseline (D1) up to month 8

• Adverse events (AEs)

  Main study: up to week 8; Six-month extension period: up to month 8

Study Arms (3)

Cohort 1

EXPERIMENTAL

Daily dose escalation (click-by-click): Starting at dose 1 in the morning with daily increments to dose 2. During the escalation phase, the dose will only be increased if the patient is feeling fine.

Drug: SAR425899

Cohort 2

EXPERIMENTAL

Weekly dose escalation in 6 escalation steps (7 dose levels): Starting at dose 1 injected in the morning with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.

Drug: SAR425899

Cohort 3

EXPERIMENTAL

Weekly dose escalation in 4 escalation steps (5 dose levels): Starting at dose 3 with weekly increments to dose 2. In case a dose level is not well tolerated by a patient, the treatment should continue at the same dose level for another 7 days before the next dose escalation.

Drug: SAR425899

Interventions

SAR425899 DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female overweight to obese subjects and type 2 diabetes mellitus (T2DM) patients not requiring anti-diabetic pharmacotherapy.
• Patients who are motivated to lose weight.

You may not qualify if:

• Type 1 diabetes mellitus.
• Body mass index \<27 kg/m2.
• Screening hemoglobin A1c (HbA1c; glycosylated hemoglobin) \>7.0%.
• Previous treatment with glucose-lowering agent(s) (eg, insulin, thiazolidinediones, metformin, DPP-IV inhibitors (dipeptidylpeptidase 4), SGLT-2 (sodium dependent glucose transporter-2) inhibitors, etc) within the last 6 months.
• Previous treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within the last 6 months.
• Uncontrolled hypertension.
• Laboratory findings at the time of screening: amylase and/or lipase \>2 times the upper limit of the normal laboratory range (ULN), alanine aminotransferase \>1.5 ULN, total bilirubin \>1.5 ULN, serum creatinine levels ≥1.5 mg/dL \[males\]. ≥1.4 mg/dL \[females\], screening calcitonin ≥20 pmol/m, fasting serum triglycerides \>400 mg/dL.
• Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC.
• History of weight loss surgery.
• History of pancreatitis or pancreatectomy.
• Pregnant or lactating women.
• Women of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 8400002

Saint Paul, Minnesota, 55144, United States

Location

Investigational Site Number 8400003

Knoxville, Tennessee, 37920, United States

Location

Investigational Site Number 8400001

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SAR425899

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 30, 2018
• Study Start: January 19, 2018
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (3)