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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK142171-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Colorado Denver - Anschutz Medical Campus (UCD-AMC) | UNKNOWN |
| Massachusetts General Hospital (MGH) | UNKNOWN |
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The objectives of this study are as follows:
Primary Objective
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly | Experimental | Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60. |
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| Dose escalation to 2 mg semaglutide weekly then no semaglutide | Experimental | Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dose escalation to 2 mg semaglutide weekly then semaglutide microdosing at 0.5 mg weekly | Drug | Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive microdosing with semaglutide at 0.5 mg subcutaneously every week during weeks 13-60. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight regain from weeks 12-60 (microdosing period) | The percent weight regain from weeks 12-60 (microdosing period), calculated as the median within-person: change in weight (kg) from weeks 60-12 (microdosing period) divided by the change in weight (kg) from weeks 12-0 (dose escalation period). | from week 12 to week 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of semaglutide microdosing in participants as indicated by total number of serious adverse events (SAEs) and adverse events (AEs) | Total number of serious adverse events (SAEs) and adverse events (AEs) will be reported. | From baseline through week 60 |
| Absolute change in weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan E Lake, MD, MSc | Contact | 713-500-6767 | Jordan.E.Lake@uth.tmc.edu | |
| Arezou S Akha | Contact | 713-500-5541 | arezou.sadighiakha@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jordan Lake, MD, MSc | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Dose escalation to 2 mg semaglutide weekly then no semaglutide | Drug | Participants will initiate semaglutide at 0.25 milligrams (mg) subcutaneously per week with dose titration up to 2.0 mg subcutaneously per week, over a total of 12 weeks. Dose titration will occur as follows: 0.25 mg weekly for 2 weeks, then 0.5 mg weekly for 2 weeks, then 1 mg weekly for 4 weeks, then 2.0 mg weekly for 4 weeks. Then, participants in this arm will receive no semaglutide during weeks 13-60. |
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| Baseline, 12 weeks, 60 weeks |
| Percent change in weight | Baseline, 12 weeks, 60 weeks |
| Absolute change in body mass index (BMI) | Baseline, 12 weeks, 60 weeks |
| Percent change in body mass index (BMI) | Baseline, 12 weeks, 60 weeks |
| Absolute change in minimum waist circumference | Baseline, 12 weeks, 60 weeks |
| Percent change in minimum waist circumference | Baseline, 12 weeks, 60 weeks |
| ID | Term |
|---|---|
| D015430 | Weight Gain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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