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CompletedNCT01155531Updated Jun 17, 2019Results posted

Safety & Tolerability of a Combination of Antidepressant and Peptic Ulcer Drug in Overweight Healthy Subjects

A Phase 1 interventional study of Sertraline plus Telenzepine in Obesity, sponsored by Theracos. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-17.

Sponsored by Theracos · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • Overweight
  • Sertraline
  • Telenzepine
  • Decrease appetite
  • Reduce appetite
  • Lose weight
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 40 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Theracos is the lead sponsor of 20 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Telenzepine - Group A

    Group A: No Sertraline; 0, 1, 2, 3 mg/day Telenzepine

    Drug: Sertraline plus Telenzepine

  • Experimental
    Sertraline plus Telenzepine - Group B

    Sertraline 50 mg/day; 0, 1, 2, 3 mg/day Telenzepine

    Drug: Sertraline plus Telenzepine

  • Experimental
    Sertraline plus Telenzepine - Group C

    Sertraline 50, 100 mg/day; 0, 1, 2, 3 mg/day Telenzepine

    Drug: Sertraline plus Telenzepine

  • Experimental
    Sertraline plus Telenzepine - Group D

    Sertraline 50, 100, 150 mg/day; 0, 1, 2, 3 mg/day Telenzepine

    Drug: Sertraline plus Telenzepine

Interventions

  • DrugSertraline plus Telenzepine

    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

06

What researchers measure

Primary outcomes

  1. 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.

    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

  2. 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.

    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.

  3. Safety of Sertraline and Telenzepine Combination

    safety of the drug combination was measured in terms of number of adverse events during the study period.

    Time frame: 7 days

07

Results

Posted Jan 9, 2013

Participant flow

Participant flow — Overall Study
MilestoneTelenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group D
Started10101010
Completed91089
Not completed1021
Withdrew: Adverse event0010
Withdrew: Lost to follow-up0001
Withdrew: Withdrawal by subject1010

Outcome measures

PrimaryChanges 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.

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
Reported as:
Mean · mm
Changes in the VAS Score From Baseline.
mmTelenzepine - Group ATelenzepine Plus Sertraline - Group BSertraline Plus Telenzepine - Group CSertraline Plus Telenzepine - Group D
1 mg of Telenzepine (30 min before breakfast)2.90 ± 28.772.70 ± 33.05-10.8 ± 25.726.70 ± 22.98
2 mg of Telenzepine (30 min before breakfast)5.50 ± 34.58-4.40 ± 24.8018.50 ± 29.38-4.5 ± 32.74
3 mg of Telenzepine (30 min before breakfast)12.22 ± 34.66-7.60 ± 25.1614.33 ± 31.86-4.60 ± 30.89
1 mg of Telenzepine (1 hour after breakfast)5.50 ± 16.64-2.40 ± 4.84-9.60 ± 40.561.20 ± 16.62
2 mg of Telenzepine (1 hour after breakfast)2.30 ± 8.18-5.20 ± 8.350.1 ± 20.906.70 ± 23.68
3 mg of Telenzepine (1 hour after breakfast)4.11 ± 13.01-7.60 ± 8.90-2.89 ± 31.853.50 ± 23.63
1 mg of Telenzepine (30 min before lunch)1.60 ± 18.76-14.50 ± 17.97-2.10 ± 26.214.60 ± 31.37
2 mg of Telenzepine (30 min before lunch)-8.60 ± 23.32-16.30 ± 18.859.60 ± 24.472.40 ± 27.59
3 mg of Telenzepine (30 min before lunch)-16.78 ± 25.37-23.40 ± 25.910.44 ± 21.90-2.70 ± 19.81
1 mg of Telenzepine (1 hour after lunch)-2 ± 15.22-3.90 ± 154.60 ± 17.1611 ± 23.32
2 mg of Telenzepine (1 hour after lunch)-1.1 ± 12.34-6.10 ± 9.215.70 ± 7.902 ± 6.77
3 mg of Telenzepine (1 hour after lunch)0.44 ± 8.95-4.60 ± 8.9112.11 ± 27.785.60 ± 22.37
1 mg of Telenzepine (30 min before supper)-4.10 ± 30.35-1.20 ± 21.879.90 ± 26.4112.50 ± 17.18
2 mg of Telenzepine (30 min before supper)-14.10 ± 19.55-10.60 ± 17.054.50 ± 26.7312.60 ± 21.61
3 mg of Telenzepine (30 min before supper)-20.67 ± 37.51-17 ± 23.05-13.33 ± 30.64-1 ± 12.46
1 mg of Telenzepine (1 hour after supper)1.70 ± 7.57-3.10 ± 16.39-17 ± 8.3813.70 ± 19.15
2 mg of Telenzepine (1 hour after supper)1.10 ± 7.78-3.30 ± 15.58-7 ± 17.33-3.30 ± 26.19
3 mg of Telenzepine (1 hour after supper)-0.78 ± 3.93-4.30 ± 14.44-6.33 ± 16.65-8.10 ± 26.44
PrimaryChanges 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.

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.
Reported as:
Mean · calorie
Changes in the Meal Calories Consumed
calorieTelenzepine - Group ATelenzepine Plus Sertraline - Group BSertraline Plus Telenzepine - Group CSertraline Plus Telenzepine - Group D
1 mg telenzepine (breakfast)-63.70 ± 76.50-42.32 ± 144.91-88.93 ± 99.56-53.91 ± 125.23
2 mg telenzepine (breakfast)36.32 ± 82.3423.70 ± 133.16-2.32 ± 78.06-67.36 ± 147.20
3 mg telenzepine (breakfast)58.59 ± 119.0480.21 ± 170.0968.21 ± 107.49-28.81 ± 144.40
1 mg telenzepine (lunch)13.98 ± 75.1214.32 ± 6659.69 ± 107.1160.92 ± 91.62
2 mg telenzepine (lunch)33.91 ± 91.7658.39 ± 129.87144.50 ± 131.5512.09 ± 111.57
3 mg telenzepine (lunch)-22.36 ± 171.6-119.01 ± 173.822.92 ± 110.29-4.94 ± 153.37
1 mg telenzepine (supper)-19.92 ± 110.8847.66 ± 62.5587.01 ± 171.07-79.49 ± 126.90
2 mg telenzepine (supper)-26.16 ± 129.51-20.85 ± 139.59-13.10 ± 182.34-12.21 ± 152.92
3 mg telenzepine (supper)9.26 ± 140.6161.88 ± 107.28-22.98 ± 183.9342.85 ± 107.91
PrimarySafety of Sertraline and Telenzepine Combination

safety of the drug combination was measured in terms of number of adverse events during the study period.

Time frame:
7 days
Reported as:
Number · number of adverse events
Safety of Sertraline and Telenzepine Combination
number of adverse eventsTelenzepine - Group ATelenzepine Plus Sertraline - Group BSertraline Plus Telenzepine - Group CSertraline Plus Telenzepine - Group D
Total10172547
Mild9152043
Moderate1244
Severe0010

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Telenzepine - Group A—0/10 (0%)4/10 (40%)
Telenzepine Plus Sertraline - Group B—0/10 (0%)9/10 (90%)
Telenzepine Plus Sertraline - Group C—0/10 (0%)8/10 (80%)
Telenzepine Plus Sertraline - Group D—0/10 (0%)10/10 (100%)
Most frequent other events
Most frequent other events
EventTelenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group D
Head acheNervous system disorders0/105/103/106/10
DiarrheaGastrointestinal disorders2/100/100/104/10
Dry mouthGastrointestinal disorders0/102/104/104/10
ConstipationGastrointestinal disorders0/100/100/104/10
NauseaGastrointestinal disorders0/100/100/101/10
Increased urinary frequencyRenal and urinary disorders1/100/101/100/10
InsomniaPsychiatric disorders1/101/100/101/10
Elevated fasting glucoseInvestigations0/101/100/100/10
Abdominal painGastrointestinal disorders1/100/101/100/10
VomittingGastrointestinal disorders0/100/101/100/10

Baseline characteristics

Age, Continuous
Age, Continuous(years)Telenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group DTotal
Mean30.7 (22 to 42)35.2 (21 to 45)33.5 (22 to 44)34.3 (22 to 45)33.4 (21 to 45)
Sex: Female, Male
Sex: Female, Male(Participants)Telenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group DTotal
Female557724
Male553316
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Telenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group DTotal
Hispanic or Latino767626
Not Hispanic or Latino343414
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Telenzepine - Group ATelenzepine Plus Sertraline - Group BTelenzepine Plus Sertraline - Group CTelenzepine Plus Sertraline - Group DTotal
American Indian or Alaska Native00101
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American23229
White867829
More than one race01001
Unknown or Not Reported00000
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01155531
Lead sponsor
Theracos
Responsible party
Sponsor
First posted
Jul 1, 2010
Start date
May 2010
Primary completion
Aug 2010
Completion
Aug 2010
Results posted
Jan 9, 2013
Last update
Jun 17, 2019

Study contacts

Jolene Berg, MD
principal investigator · Cetero Research, San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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