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
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.
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 →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.
Exclusion Criteria:
Group A: No Sertraline; 0, 1, 2, 3 mg/day Telenzepine
Drug: Sertraline plus Telenzepine
Sertraline 50 mg/day; 0, 1, 2, 3 mg/day Telenzepine
Drug: Sertraline plus Telenzepine
Sertraline 50, 100 mg/day; 0, 1, 2, 3 mg/day Telenzepine
Drug: Sertraline plus Telenzepine
Sertraline 50, 100, 150 mg/day; 0, 1, 2, 3 mg/day Telenzepine
Drug: Sertraline 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
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
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.
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
| Milestone | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D |
|---|---|---|---|---|
| Started | 10 | 10 | 10 | 10 |
| Completed | 9 | 10 | 8 | 9 |
| Not completed | 1 | 0 | 2 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 0 |
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.
| mm | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Sertraline Plus Telenzepine - Group C | Sertraline Plus Telenzepine - Group D |
|---|---|---|---|---|
| 1 mg of Telenzepine (30 min before breakfast) | 2.90 ± 28.77 | 2.70 ± 33.05 | -10.8 ± 25.72 | 6.70 ± 22.98 |
| 2 mg of Telenzepine (30 min before breakfast) | 5.50 ± 34.58 | -4.40 ± 24.80 | 18.50 ± 29.38 | -4.5 ± 32.74 |
| 3 mg of Telenzepine (30 min before breakfast) | 12.22 ± 34.66 | -7.60 ± 25.16 | 14.33 ± 31.86 | -4.60 ± 30.89 |
| 1 mg of Telenzepine (1 hour after breakfast) | 5.50 ± 16.64 | -2.40 ± 4.84 | -9.60 ± 40.56 | 1.20 ± 16.62 |
| 2 mg of Telenzepine (1 hour after breakfast) | 2.30 ± 8.18 | -5.20 ± 8.35 | 0.1 ± 20.90 | 6.70 ± 23.68 |
| 3 mg of Telenzepine (1 hour after breakfast) | 4.11 ± 13.01 | -7.60 ± 8.90 | -2.89 ± 31.85 | 3.50 ± 23.63 |
| 1 mg of Telenzepine (30 min before lunch) | 1.60 ± 18.76 | -14.50 ± 17.97 | -2.10 ± 26.21 | 4.60 ± 31.37 |
| 2 mg of Telenzepine (30 min before lunch) | -8.60 ± 23.32 | -16.30 ± 18.85 | 9.60 ± 24.47 | 2.40 ± 27.59 |
| 3 mg of Telenzepine (30 min before lunch) | -16.78 ± 25.37 | -23.40 ± 25.91 | 0.44 ± 21.90 | -2.70 ± 19.81 |
| 1 mg of Telenzepine (1 hour after lunch) | -2 ± 15.22 | -3.90 ± 15 | 4.60 ± 17.16 | 11 ± 23.32 |
| 2 mg of Telenzepine (1 hour after lunch) | -1.1 ± 12.34 | -6.10 ± 9.21 | 5.70 ± 7.90 | 2 ± 6.77 |
| 3 mg of Telenzepine (1 hour after lunch) | 0.44 ± 8.95 | -4.60 ± 8.91 | 12.11 ± 27.78 | 5.60 ± 22.37 |
| 1 mg of Telenzepine (30 min before supper) | -4.10 ± 30.35 | -1.20 ± 21.87 | 9.90 ± 26.41 | 12.50 ± 17.18 |
| 2 mg of Telenzepine (30 min before supper) | -14.10 ± 19.55 | -10.60 ± 17.05 | 4.50 ± 26.73 | 12.60 ± 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 ± 8.38 | 13.70 ± 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 |
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.
| calorie | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Sertraline Plus Telenzepine - Group C | Sertraline 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 ± 82.34 | 23.70 ± 133.16 | -2.32 ± 78.06 | -67.36 ± 147.20 |
| 3 mg telenzepine (breakfast) | 58.59 ± 119.04 | 80.21 ± 170.09 | 68.21 ± 107.49 | -28.81 ± 144.40 |
| 1 mg telenzepine (lunch) | 13.98 ± 75.12 | 14.32 ± 66 | 59.69 ± 107.11 | 60.92 ± 91.62 |
| 2 mg telenzepine (lunch) | 33.91 ± 91.76 | 58.39 ± 129.87 | 144.50 ± 131.55 | 12.09 ± 111.57 |
| 3 mg telenzepine (lunch) | -22.36 ± 171.6 | -119.01 ± 173.82 | 2.92 ± 110.29 | -4.94 ± 153.37 |
| 1 mg telenzepine (supper) | -19.92 ± 110.88 | 47.66 ± 62.55 | 87.01 ± 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 ± 140.61 | 61.88 ± 107.28 | -22.98 ± 183.93 | 42.85 ± 107.91 |
safety of the drug combination was measured in terms of number of adverse events during the study period.
| number of adverse events | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Sertraline Plus Telenzepine - Group C | Sertraline Plus Telenzepine - Group D |
|---|---|---|---|---|
| Total | 10 | 17 | 25 | 47 |
| Mild | 9 | 15 | 20 | 43 |
| Moderate | 1 | 2 | 4 | 4 |
| Severe | 0 | 0 | 1 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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%) |
| Event | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D |
|---|---|---|---|---|
| Head acheNervous system disorders | 0/10 | 5/10 | 3/10 | 6/10 |
| DiarrheaGastrointestinal disorders | 2/10 | 0/10 | 0/10 | 4/10 |
| Dry mouthGastrointestinal disorders | 0/10 | 2/10 | 4/10 | 4/10 |
| ConstipationGastrointestinal disorders | 0/10 | 0/10 | 0/10 | 4/10 |
| NauseaGastrointestinal disorders | 0/10 | 0/10 | 0/10 | 1/10 |
| Increased urinary frequencyRenal and urinary disorders | 1/10 | 0/10 | 1/10 | 0/10 |
| InsomniaPsychiatric disorders | 1/10 | 1/10 | 0/10 | 1/10 |
| Elevated fasting glucoseInvestigations | 0/10 | 1/10 | 0/10 | 0/10 |
| Abdominal painGastrointestinal disorders | 1/10 | 0/10 | 1/10 | 0/10 |
| VomittingGastrointestinal disorders | 0/10 | 0/10 | 1/10 | 0/10 |
| Age, Continuous(years) | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D | Total |
|---|---|---|---|---|---|
| Mean | 30.7 (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(Participants) | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D | Total |
|---|---|---|---|---|---|
| Female | 5 | 5 | 7 | 7 | 24 |
| Male | 5 | 5 | 3 | 3 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 7 | 6 | 26 |
| Not Hispanic or Latino | 3 | 4 | 3 | 4 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Telenzepine - Group A | Telenzepine Plus Sertraline - Group B | Telenzepine Plus Sertraline - Group C | Telenzepine Plus Sertraline - Group D | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 2 | 2 | 9 |
| White | 8 | 6 | 7 | 8 | 29 |
| More than one race | 0 | 1 | 0 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Theracos