ObesityPhase 1NCT01155531
Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects
A Phase 1 study testing Sertraline plus Telenzepine in people with Obesity, run by Theracos.
Trial summary
The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine will be safe, tolerable, and have the effect of suppressing appetite, when taken in combination daily by mouth by healthy, overweight, adult men and women. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sertraline plus Telenzepine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Aug 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In good health based on medical history, physical examination, ECG, routine laboratory tests, and BMI >/= 30 kg/m2 and </=30 40 kg/m^2.
- Males and females agree to use described birth control methods.
- Non-smoker.
- Willing and able to be confined to the clinical research facility.
- Willing and able to comply with the protocol and able to communicate with investigators.
- Able to comprehend and willing to provide written informed consent.
Who cannot join
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies; patients with untreated, asymptomatic, seasonal allergies may be enrolled), surgical conditions, cancer or any other condition that might in the opinion of the investigator impair the ability of the subject to complete the study or significantly interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
- Evidence or history of clinically significant psychiatric disease including major depression, mania, or hypomania, and history of suicide attempts or suicidal ideation. Subjects with a Beck Depression Inventory-II (BDI-II) score >13 at screening are excluded.
- Clinically relevant abnormal findings at the screening examination (including laboratory tests and ECG).
- Screening ECG which demonstrates at least one of the following: heart rate > 100 bpm, QRS > 120 msec, QTc > 450 msec, PR > 220 msec or any rhythm other than sinus rhythm, sinus bradycardia, or sinus arrhythmia.
- Change in weight > 5 kilograms within 3 months of screening.
- History of alcohol consumption exceeding 14 drinks/week (1 drink equaling 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) within the 6 months before study entry.
Show all 19Show fewer
- Sitting systolic blood pressure ≤90 millimeters of mercury (mmHg) or ≥140 mmHg, diastolic blood pressure </= 50 mmHg or >/= 90 mmHg and judged to be clinically significant by the investigator.
- Positive result on drug screen, hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency (HIV) tests.
- Use of prescription or non-prescription drugs, vitamins, or dietary supplements within 14 days prior to the first dose of study medication. Subjects on oral contraceptives and subjects who have used acetaminophen at doses of < 2 grams/day are eligible for study entry. Any exception to this must be felt not to impact the integrity of the data and must be jointly agreed upon by the investigator and medical monitor.
- Treatment with any investigational drug, use of any known CYP450 enzyme- inducing/inhibiting agents (e.g., barbiturates, phenothiazines, cimetidine, St. John's Wort) or herbal supplements within 30 days prior to the first dose of study medication.
- Treatment with any psychotropic medication within 90 days of screening.
- History of drug abuse or dependence within 180 days of screening.
- Febrile illness within 5 days prior to the first dose of study medication.
- Inadequate venous access.
- Known allergy to sertraline or telenzepine.
- History of an active eating disorder such as anorexia nervosa, bulimia or binge eating disorder.
- Elevated ALT (> 2X ULN) or total bilirubin (> 1.6 mg/dL)
- Have diabetes mellitus (fasting plasma glucose > 126 mg/dL)
- Have been on weight loss medications in the past 6 months
About this study
Official title: A Phase I, Single Center, Open Label, Intra Subject, Dose Escalation Study to Evaluate Safety and Tolerability of Sertraline Plus Telenzepine in Overweight Healthy Subjects
The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine will be safe, tolerable, and have the effect of suppressing appetite, when taken in combination daily by mouth by healthy, overweight, adult men and women.
In this study, up to 12 people will be assigned to one of 4 groups: A, B, C, and D, and will receive 0, 50, 100, or 150 mg of sertraline per day. People in Groups B, C, or D will receive an initial dose of 50 mg sertraline. People in Groups C and D will receive an additional 50 mg of sertraline per week.
Read more
Up to 10 people from each group who were able to tolerate their sertraline dose for at least 5 days will begin taking 50 mg of sertraline plus doses of telenzepine that will increase from 1 mg to 2 mg to 3 mg over a 7-day period (they will receive each combination). On the day before they begin taking this combination of drugs, their appetite will be evaluated (on a visual scale of 0 to 100) before and after 3 meals.
The appetites of each person, assessed by the visual scale, will be evaluated on the last day of the period (Day 7) before and after 3 meals of each combination treatment, while they are staying in the research unit. The amount of food they eat will be determined.
Based on safety and tolerability assessments of individuals, and of the previous groups who received lower doses of the combination of drug, a decision will be made whether to further increase the dose of these drugs.
Since the appetites of each person will be evaluated on the last day of the period (Day 7) before and after 3 meals of each combination treatment, people in this study will stay in the research unit for approximately 2½ days, starting on Day 6 of their previous treatment, so appetite evaluations can be made on Day 7 after a fixed meal in the evening of Day 6. These people will continue the stay in the research unit when they begin each telenzepine dose increase, so a 24 hour safety observation may be made immediately after the increase.
After the final doses of telenzepine have been received, people in Groups C and D will continue to receive sertraline 50 mg per day for an additional 7 days or until the study physician decides when sertraline should be discontinued. People will return to the study unit for final visit, 2 weeks after they have received their last sertraline dose.
- Conditions
- Obesity
- Being tested
- Sertraline plus Telenzepine
- Keywords
- Obesity, Overweight, Sertraline, Telenzepine, Decrease appetite, Reduce appetite, Lose weight
- Medical subject headings
- Obesity, Overweight, Anorexia, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sertraline plus TelenzepineDrug
oral sertraline tablets at 0, 50, 100, or 150/day plus oral telenzepine capsules at 0, 1, 2, or 3 mg/day for 7 days in each combination
| Study group | Role | What they receive |
|---|---|---|
| Telenzepine - Group A | Experimental | Group A: No Sertraline; 0, 1, 2, 3 mg/day Telenzepine Receives: Drug: Sertraline plus Telenzepine |
| Sertraline plus Telenzepine - Group B | Experimental | Sertraline 50 mg/day; 0, 1, 2, 3 mg/day Telenzepine Receives: Drug: Sertraline plus Telenzepine |
| Sertraline plus Telenzepine - Group C | Experimental | Sertraline 50, 100 mg/day; 0, 1, 2, 3 mg/day Telenzepine Receives: Drug: Sertraline plus Telenzepine |
| Sertraline plus Telenzepine - Group D | Experimental | Sertraline 50, 100, 150 mg/day; 0, 1, 2, 3 mg/day Telenzepine Receives: Drug: Sertraline plus Telenzepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the VAS Score From Baseline.
The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: "How hungry are you now?" The anchor points of the 100mm scale were "I am not hungry at all" and "Never more hungry" corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.
Measured: The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal
Changes in the Meal Calories Consumed
The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.
Measured: The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.
Safety of Sertraline and Telenzepine Combination
safety of the drug combination was measured in terms of number of adverse events during the study period.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theracos
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jolene Berg, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155531
- Sponsor's protocol ID
- THR-4450-C-401
- Status last verified
- Jun 2019
- First submitted
- 22 Jun 2010
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single Center, Open Label, Intra Subject, Dose Escalation Study to Evaluate Safety and Tolerability of Sertraline Plus Telenzepine in Overweight Healthy Subjects
- ClinicalTrials.gov ID
- NCT01155531
- Acronym / sponsor ID
- THR-4450-C-401
- Conditions
- Obesity
- Keywords
- Obesity, Overweight, Sertraline, Telenzepine, Decrease appetite, Reduce appetite, Lose weight
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TheracosIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Posted 9 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis of this study is that up to 150 mg of sertraline and up to 3 mg of telenzepine will be safe, tolerable, and have the effect of suppressing appetite, when taken in combination daily by mouth by healthy, overweight, adult men and women.
In this study, up to 12 people will be assigned to one of 4 groups: A, B, C, and D, and will receive 0, 50, 100, or 150 mg of sertraline per day. People in Groups B, C, or D will receive an initial dose of 50 mg sertraline. People in Groups C and D will receive an additional 50 mg of sertraline per week.
Up to 10 people from each group who were able to tolerate their sertraline dose for at least 5 days will begin taking 50 mg of sertraline plus doses of telenzepine that will increase from 1 mg to 2 mg to 3 mg over a 7-day period (they will receive each combination). On the day before they begin taking this combination of drugs, their appetite will be evaluated (on a visual scale of 0 to 100) before and after 3 meals.
The appetites of each person, assessed by the visual scale, will be evaluated on the last day of the period (Day 7) before and after 3 meals of each combination treatment, while they are staying in the research unit. The amount of food they eat will be determined.
Based on safety and tolerability assessments of individuals, and of the previous groups who received lower doses of the combination of drug, a decision will be made whether to further increase the dose of these drugs.
Since the appetites of each person will be evaluated on the last day of the period (Day 7) before and after 3 meals of each combination treatment, people in this study will stay in the research unit for approximately 2½ days, starting on Day 6 of their previous treatment, so appetite evaluations can be made on Day 7 after a fixed meal in the evening of Day 6. These people will continue the stay in the research unit when they begin each telenzepine dose increase, so a 24 hour safety observation may be made immediately after the increase.
After the final doses of telenzepine have been received, people in Groups C and D will continue to receive sertraline 50 mg per day for an additional 7 days or until the study physician decides when sertraline should be discontinued. People will return to the study unit for final visit, 2 weeks after they have received their last sertraline dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telenzepine - Group A | Experimental | Drug: Sertraline plus TelenzepineGroup A: No Sertraline; 0, 1, 2, 3 mg/day Telenzepine |
| Sertraline plus Telenzepine - Group B | Experimental | Drug: Sertraline plus TelenzepineSertraline 50 mg/day; 0, 1, 2, 3 mg/day Telenzepine |
| Sertraline plus Telenzepine - Group C | Experimental | Drug: Sertraline plus TelenzepineSertraline 50, 100 mg/day; 0, 1, 2, 3 mg/day Telenzepine |
| Sertraline plus Telenzepine - Group D | Experimental | Drug: Sertraline plus TelenzepineSertraline 50, 100, 150 mg/day; 0, 1, 2, 3 mg/day Telenzepine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In good health based on medical history, physical examination, ECG, routine laboratory tests, and BMI >/= 30 kg/m2 and </=30 40 kg/m^2.
- Males and females agree to use described birth control methods.
- Non-smoker.
- Willing and able to be confined to the clinical research facility.
- Willing and able to comply with the protocol and able to communicate with investigators.
Key exclusion criteria (19 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, or allergic disease (including drug allergies; patients with untreated, asymptomatic, seasonal allergies may be enrolled), surgical conditions, cancer or any other condition that might in the opinion of the investigator impair the ability of the subject to complete the study or significantly interfere with the absorption, distribution, metabolism, or excretion of the study drugs.
- Evidence or history of clinically significant psychiatric disease including major depression, mania, or hypomania, and history of suicide attempts or suicidal ideation. Subjects with a Beck Depression Inventory-II (BDI-II) score >13 at screening are excluded.
- Clinically relevant abnormal findings at the screening examination (including laboratory tests and ECG).
- Screening ECG which demonstrates at least one of the following: heart rate > 100 bpm, QRS > 120 msec, QTc > 450 msec, PR > 220 msec or any rhythm other than sinus rhythm, sinus bradycardia, or sinus arrhythmia.
- Change in weight > 5 kilograms within 3 months of screening.
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 |
|---|---|---|
| Sertraline plus Telenzepineoral sertraline tablets at 0, 50, 100, or 150/day plus oral telenzepine capsules at 0, 1, 2, or 3 mg/day for 7 days in each combination | Drug | Sertraline plus Telenzepine - Group B, Sertraline plus Telenzepine - Group C, Sertraline plus Telenzepine - Group D, Telenzepine - Group A |
Primary outcome
Changes in the VAS Score From Baseline.
Time frame: The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal
The baseline VAS self-assessment was completed for each subject on day 7 of each dose combination. Appetite VAS was completed in the subject's room approximately 30 min before and 1 h after each meal serving. Appetite was not assessed prior to snacks. VAS assessment was based on response to the question: "How hungry are you now?" The anchor points of the 100mm scale were "I am not hungry at all" and "Never more hungry" corresponding to 0 mm and 100 mm respectively. The subjects' VAS scores were measured by the clinic staff and entered into the CRF. The description listed below (VAS after meal minus and VAS before meal) refers only to the mean VAS score of each group.
Changes in the Meal Calories Consumed
Time frame: The baseline was defined as on day 7 of sertraline treatment with no telenzepine. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.
The changes in the meal calories consumed was measured upon telenzepine treatment at the dose of 1 mg, 2 mg and 3 mg (i.e. end of every 7 days). The baseline was defined as on day 7 of sertraline treatment with no telenzepine for the specified meal. Food consumption was measured as calories consumed for breakfast, lunch, and dinner for all treatment groups on day 7 of each dose combination.
Safety of Sertraline and Telenzepine Combination
Time frame: 7 days
safety of the drug combination was measured in terms of number of adverse events during the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jolene Berg, MD principal investigator
Cetero Research, San Antonio
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sertraline plus Telenzepine in people with Obesity, run by Theracos.
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 6 inclusion and 19 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 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in the VAS Score From Baseline. (time frame: The baseline was defined on day 7 of sertraline treatment with no telenzepine before and meal. Appetite VAS was measured 30 min before and 1hour after to meal). The study lists 3 primary outcomes in all. 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 17 Jun 2019.