Type 2 Diabetes MellitusPhase 1NCT03376802
A Clinical Study to Investigate the Effect of SAR425899 on Energy Expenditure in Obese Subjects
A Phase 1 study testing SAR425899 in people with Type 2 Diabetes Mellitus, run by Sanofi at 2 sites in United States.
Trial summary
Primary Objective: To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899. Secondary Objectives: To assess the change in resting, basal and total daily energy expenditure. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- SAR425899
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2018to 27 Dec 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight to obese male and female subjects.
- Body mass index 28 - 40 kg/m2.
- 18 to 50 years of age
- Fasting plasma glucose ≤125 mg/dL.
- Glycated hemoglobine (HbA1c) ≤6.5%.
- Obesity associated mild concomitant diseases allowed (eg, mild hypertension, mild hypercholesteremia, and hyperlipidemia).
- No concomitant medication allowed except stable treatment with statins or antihypertensive drugs (except ß-blocker).
- Females should be either postmenopausal, or, if perimenopausal should have a normal regular menstrual cycle and should start or continue stable treatment with a monophasic oral contraceptive.
Who cannot join
- Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
- Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.
- Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.
- 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
2 sites in 1 country.
United States2 sites
Investigational Site Number 8400002
Baton Rouge, Louisiana, 70808
Investigational Site Number 8400001
Orlando, Florida, 32804
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects
Primary Objective:
To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.
Secondary Objectives:
- To assess the change in resting, basal and total daily energy expenditure.
- To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.
- To assess the change in body composition and core temperature.
- To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).
- To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.
- To assess the safety and tolerability.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- SAR425899, Placebo
- 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
PlaceboDrug
Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| SAR425899 | Experimental | Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days Receives: Drug: SAR425899 |
| Placebo | Placebo comparator | Repeated once daily SC doses of placebo administered over 19 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep energy expenditure
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
Measured: Baseline to Day 19
Secondary outcomes (15)
Total daily energy expenditure
Change of total energy expenditure from baseline to Day 19 with SAR425899 or placebo
Measured: Baseline to Day 19
Resting energy expenditure
Change of resting energy expenditure from baseline to Day 19 with SAR425899 or placebo
Measured: Baseline to Day 19
Basal energy expenditure
Change of basal energy expenditure from baseline to Day 19 with SAR425899 or placebo
Measured: Baseline to Day 19
Respiratory quotient (RQ)
Change of respiratory quotient from baseline to Day 19 with SAR425899 or placebo
Measured: 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
Measured: Baseline to Day 20
Diet Induced Thermogenesis (DIT)
Change of DIT from baseline to Day 19 with SAR425899 or placebo
Measured: Baseline to Day 19
Fasting plasma glucose
Change of FPG over time with SAR425899 or placebo
Measured: 20 days
HbA1c
Change of HbA1c from baseline to Day 20 with SAR425899 or placebo
Measured: 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
Measured: 20 days
Ketone bodies
Change of ketone bodies over time with SAR425899 or placebo
Measured: 20 days
Adverse events
Number of adverse events in patients under treatment with SAR425899 or placebo
Measured: Up to 27 days
Pharmacokinetics
Assessment of SAR425899: time to reach Cmax (tmax)
Measured: Day 16
Pharmacokinetics
Assessment of SAR425899: maximum plasma concentration (Cmax)
Measured: Day 16
Pharmacokinetics
Assessment of SAR425899: area under the concentration versus time curve (AUC)
Measured: Day 16
Pharmacokinetics
Assessment of SAR425899: terminal elimination half-life (t1/2)
Measured: Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start18 Apr 2018
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376802
- Sponsor's protocol ID
- PDY15012
- Other IDs
- U1111-1191-5658
- Status last verified
- Apr 2022
- First submitted
- 12 Dec 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Repeated Subcutaneous Doses of SAR425899 on Energy Expenditure and Safety in Overweight to Obese Male and Female Subjects
- ClinicalTrials.gov ID
- NCT03376802
- Acronym / sponsor ID
- PDY15012
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
To assess in overweight to obese subjects the change in sleep energy expenditure after repeated subcutaneous (SC) doses of SAR425899.
Secondary Objectives:
- To assess the change in resting, basal and total daily energy expenditure.
- To assess the change in respiratory quotient, fat, protein and carbohydrate oxidation.
- To assess the change in body composition and core temperature.
- To assess the pharmacodynamic effects on fasting plasma glucose, biomarkers of lipid metabolism and glycated hemoglobin (HbA1c).
- To assess the pharmacokinetic parameters for SAR425899 after repeated SC doses.
- To assess the safety and tolerability.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAR425899 | Experimental | Drug: SAR425899Repeated once daily subcutaneous (SC) doses of SAR425899 administered over 19 days |
| Placebo | Placebo comparator | Drug: PlaceboRepeated once daily SC doses of placebo administered over 19 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Overweight to obese male and female subjects.
- Body mass index 28 - 40 kg/m2.
- 18 to 50 years of age
- Fasting plasma glucose ≤125 mg/dL.
- Glycated hemoglobine (HbA1c) ≤6.5%.
Key exclusion criteria (4 listed)
- Elevated liver enzymes, lipase, amylase, or calcitonin at screening.
- Current participation in an organized diet / weight reduction program or clinical trial of weight control or weight loss attempt, plans for major changes in physical activities or significant change in body weight in the 2 months prior to screening.
- Any condition possibly affecting gastric emptying or absorption from gastro-intestinal tract (eg, gastric surgery, gastrectomy, bariatric surgery, malabsorption syndromes, gastroparesis, abdominal surgery other than appendectomy or hysterectomy.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR425899Pharmaceutical form: Solution for injection Route of administration: Subcutaneous | Drug | SAR425899 |
| PlaceboPharmaceutical form: Solution for injection Route of administration: Subcutaneous | Drug | Placebo |
Primary outcome
Sleep energy expenditure
Time frame: Baseline to Day 19
Change of sleep energy expenditure from baseline to Day 19 with SAR425899 or placebo
15 secondary outcomes
Total daily energy expenditure
Time frame: Baseline to Day 19
Resting energy expenditure
Time frame: Baseline to Day 19
Basal energy expenditure
Time frame: Baseline to Day 19
Respiratory quotient (RQ)
Time frame: Baseline to Day 19
Fat mass and fat-free mass
Time frame: Baseline to Day 20
Diet Induced Thermogenesis (DIT)
Time frame: Baseline to Day 19
Fasting plasma glucose
Time frame: 20 days
HbA1c
Time frame: Baseline to Day 20
Lipid biomarker (free fatty acids, triglycerides, total cholesterol, HDL-/LDL-cholesterol)
Time frame: 20 days
Ketone bodies
Time frame: 20 days
Adverse events
Time frame: Up to 27 days
Pharmacokinetics
Time frame: Day 16
Pharmacokinetics
Time frame: Day 16
Pharmacokinetics
Time frame: Day 16
Pharmacokinetics
Time frame: Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR425899 in people with Type 2 Diabetes Mellitus, run by Sanofi at 2 sites in United States.
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 8 inclusion and 4 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 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Sleep energy expenditure (time frame: Baseline to Day 19). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.