A Phase 2 interventional study of SAR425899 and Placebo in Non-alcoholic Steatohepatitis and Type 2 Diabetes Mellitus, sponsored by Sanofi. Withdrawn. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-13.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
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Primary Objective:
Secondary Objectives:
Study duration per participant will be approximately 64 weeks, consisting of up to 8 weeks screening plus 52 weeks treatment and 4 weeks post treatment follow-up.
1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.
Browse Non-alcoholic Fatty Liver Disease studies →Sanofi is the lead sponsor of 1,558 studies on the registry; 89 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once daily dose with weekly dose escalations, if tolerated, until target dose is reached. From week 14 (Day 99) until week 52, no further dose adjustments are planned.
Drug: SAR425899
Once daily dose with weekly dose escalations, if tolerated, until target dose is reached. From week 14 (Day 99) until week 52, no further dose adjustments are planned.
Drug: SAR425899
Once daily dose with weekly dose escalations, if tolerated, until target dose is reached. From week 14 (Day 99) until week 52, no further dose adjustments are planned.
Drug: Placebo
Once daily dose with weekly dose escalations, if tolerated, until target dose is reached. From week 14 (Day 99) until week 52, no further dose adjustments are planned.
Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
Resolution of Non-alcoholic steatohepatitis (NASH)
Percentage of participants with absence of hepatocyte ballooning (NAFLD - non-alcoholic fatty liver disease - activity score, NAS = 0) without worsening of fibrosis score at week 52. -
Time frame: Week 52
No hepatocyte ballooning, lobular inflammation score 0 or 1, without worsening of fibrosis
Percentage of participants with absence of hepatocyte ballooning (NAS = 0), lobular inflammation NAS = 0 or 1, without worsening of fibrosis score at week 52.
Time frame: Week 52
Change in overall NAFLD activity score (NAS)
Change from baseline to week 52 in overall NAFLD activity score (NAS).
Time frame: Baseline to week 52
Change in NAS individual components
Change from baseline to week 52 in individual components of NAS (steatosis).
Time frame: Baseline to week 52
Change in NAS individual components
Change from baseline to week 52 in individual components of NAS (hepatocyte ballooning).
Time frame: Baseline to week 52
Change in NAS individual components
Change from baseline to week 52 in individual components of NAS (lobular inflammation).
Time frame: Baseline to week 52
Change in fibrosis score
Change from baseline to week 52 in fibrosis score.
Time frame: Baseline to week 52
Major adverse cardiac events
Number of patients with major cardiac events
Time frame: Baseline to week 52
Change in Magnetic Resonance Imaging-determined Proton Density Fat Fraction (MRI-PDFF)
Change from baseline to week 26 and to week 52 in MRI-PDFF-derived total liver fat, liver volume and fractional liver fat content.
Time frame: Baseline to week 26 and week 52
Improvement of fibrosis without worsening of hepatocyte ballooning component of NAS
Percentage of participants with improvement of fibrosis by at least 1 stage without worsening of hepatocyte ballooning component of NAS at week 52
Time frame: Week 52
Change in body weight
Change from baseline to week 52 in body weight
Time frame: Baseline to week 52
Change in waist circumference
Change from baseline to week 52 in waist circumference
Time frame: Baseline to week 52
Change in hip circumference
Change from baseline to week 52 in hip circumference
Time frame: Baseline to week 52
Change in waist to hip ratio
Change from baseline to week 52 in waist to hip ratio
Time frame: Baseline to week 52
Assessment of pharmacokinetic (PK) parameter: AUC0-24
Area under the concentration-time curve from 0 to 24 hours (AUC0-24)
Time frame: Week 52
Assessment of PK parameter: Cmax
Observed maximum plasma concentration after administration (Cmax)
Time frame: Week 52
Assessment of PK parameter: Ctrough
Plasma concentration immediately prior to treatment administration during repeat dosing levels (Ctrough)
Time frame: Baseline to week 52
No study locations are listed for this record.
Plan to share: 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
No publications or documents are linked to this record.
Start is estimated for May 2019; primary completion for Aug 2021, 27 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: SAR425899
Non-alcoholic Fatty Liver Disease →