A Phase 1 interventional study of SAR425899 and Placebo in Type 2 Diabetes Mellitus, sponsored by Sanofi. Completed at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Sanofi · Phase 1, Interventional, and Basic science
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Among 186 studies in Diabetes Mellitus, Type 2 by Sanofi — 1 open to participants now, 1 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Sanofi.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, this one is the 160th largest by enrollment of the 178 interventional ones that give a count, is one of 12 that started in 2018, is one of 16 in phase 1, and was the 157th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →1 of the 186 studies in Diabetes Mellitus, Type 2 by Sanofi is open now, in 1 country. Recruiting first, the newest first:
Sanofi · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
186 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 24 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 334 across the 178 interventional studies, 1,229 across the 5 observational. Of the 183 that completed or were terminated, 46 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
None of the studies under way reaches primary completion within a year.
Among the 186 studies in Diabetes Mellitus, Type 2 by Sanofi, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Primary Objective:
To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.
Secondary Objectives:
Study duration is approximately 7-8 weeks including a screening period, a 19-day treatment period and an end-of-study visit 7 days after last dosing.
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.
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 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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days
Drug: SAR425899
Repeated once daily SC doses of placebo administered over 19 days
Drug: Placebo
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Sleep energy expenditure
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Total daily energy expenditure
Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Resting energy expenditure
Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Basal energy expenditure
Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Respiratory quotient (RQ)
Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Fat mass and fat-free mass
Change of fat mass and fat-free mass by dual energy X-ray absorptiometry (DEXA) scan from baseline to Day 20 with SAR425899 or placebo
Time frame: Baseline to Day 20
Diet Induced Thermogenesis (DIT)
Change of DIT from baseline to Day 19 with SAR425899 or placebo
Time frame: Baseline to Day 19
Fasting plasma glucose
Change of FPG over time with SAR425899 or placebo
Time frame: 20 days
HbA1c
Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
Time frame: Baseline to Day 20
Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)
Change of lipid biomarkers over time with SAR425899 or placebo
Time frame: 20 days
Ketone bodies
Change of ketone bodies over time with SAR425899 or placebo
Time frame: 20 days
Adverse events
Number of adverse events in patients under treatment with SAR425899 or placebo
Time frame: Up to 27 days
Pharmacokinetics
Assessment of SAR425899: time to reach Cmax (tmax)
Time frame: Day 16
Pharmacokinetics
Assessment of SAR425899: maximum plasma concentration (Cmax)
Time frame: Day 16
Pharmacokinetics
Assessment of SAR425899: area under the concentration versus time curve (AUC)
Time frame: Day 16
Pharmacokinetics
Assessment of SAR425899: terminal elimination half-life (t1/2)
Time frame: Day 16
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.
Ran from Apr 2018 to primary completion in Dec 2018, 8 months.
Of 453 industry-sponsored phase 1 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 11. This study's 8 months is above that.
Counting every sponsor, half of 515 studies reached it within 6 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is completed, 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