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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK099039-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.
A randomized, double-blind, placebo-controlled 12-week study with GLP-1 analogue (semaglutide) in men and women with obesity (BMI 30-49.9 kg/m2) in a validated laboratory model to identifying processes underlying greater food craving, intake and weight change, in order to test mechanisms by which a GLP-1 analogues may exerts significant weight effects in obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLP-1a | Experimental | GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks |
|
| Placebo | Placebo Comparator | Placebo pen administered weekly over 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLP-1 analogue - semaglutide | Drug | GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Craving Score | Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment. | Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0. |
| Change in Hunger Score | Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment. | Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS) |
| Change in Food Intake | Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment. | Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Food Intake - Real-World | Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment. | Average change from baseline to end of treatment (Kcalories at week 12 - week 0) |
| Change in Stress Score |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Percent change in Weight in kilograms will be assessed using a bioimpedance scale. higher negative score indicates greater change with treatment. | Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ania Jastreboff, MD, PhD | Internal Medicine (Endocrinology) and Pediatrics (Pediatric Endocrinology); | Principal Investigator |
| Rajita Sinha, PhD | Psychiatry; Director Yale Stress Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Yale Stress Center: Yale University | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GLP-1a | GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks |
| FG001 | Placebo | Placebo pen administered weekly over 12 weeks Placebo: Placebo - administered once weekly for a total of 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics presented are for those that completed.
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| ID | Title | Description |
|---|---|---|
| BG000 | GLP-1a | GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Craving Score | Change in craving score will be measured using a validated and revised questionnaire called Food Craving Inventory (FCI-R). FCI-R is an 28-item questionnaire that measures how often participants experienced specific food cravings for each of 28 different food types. Participants can respond to each item from "not at all" (score=1) to "more than ever" (score=5), with total FCI-R score range of 28-140. Higher mean scores indicate greater average food craving. A negative change indicates a decrease in craving with treatment. | Posted | Mean | Standard Deviation | score | Average change in avg FCI craving score from week 0 to end of treatment (week 12) computed as avg FCI score at week 12 - avg FCI score at Week 0. |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GLP-1a | GLP-1a Semaglutide target dose of 1.2 mg administered weekly over 12 weeks GLP-1 analogue - semaglutide: GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | Systematic Assessment | Chest Pain Requiring Overnight Evaluation in ED Cardiac Observation Unit- Deemed "Muscle Strain" |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ania Jastreboff, MD, PhD | Yale University / Yale School of Medicine | 203-737-1932 | ania.jastreboff@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2024 | Oct 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2023 | Oct 31, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| Placebo | Other | Placebo - administered once weekly for a total of 12 weeks |
|
Stress, measured as total summed score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. A negative change indicates lower stress with treatment. The Perceived Stress Scale (PSS)-14 has a total score range of 0 to 56, with individual items scored from 0 ("Never") to 4 ("Very often") and positively worded items reverse-scored before summing. |
| Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0) |
Placebo pen administered weekly over 12 weeks
Placebo: Placebo - administered once weekly for a total of 12 weeks
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Years of Education | Mean | Standard Deviation | years |
|
| Regularly Use Substances | Count of Participants | Participants |
|
| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Placebo | Placebo pen administered weekly over 12 weeks Placebo: Placebo - administered once weekly for a total of 12 weeks |
|
|
|
| Primary | Change in Hunger Score | Hunger will be measured in a Visual Analog Scale (VAS) range from 0 to 10. Higher VAS indicates greater hunger. Negative change in score indicates less hunger with treatment. | Data presented here is for all participants that completed the assessment. | Posted | Mean | Standard Deviation | score | Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS) |
|
|
|
|
| Primary | Change in Food Intake | Food intake will be measured in total calorie energy density during a validated observed laboratory task called the Food Snack Test (FST).Negative change indicates a lower food intake with treatment. | Data presented here is for all participants that completed the assessment. | Posted | Mean | Standard Deviation | Kcalories | Change in FST total calorie energy density (totalcalED)from FST at week 0 and FST during treatment at week 12 (week 12 FST - Week 0 FST totalcalED change) |
|
|
|
|
| Secondary | Change in Food Intake - Real-World | Food intake will be measured in Kcalories using 3-day 24hr recall (ASA24). A negative change indicates lower food intake with treatment. | Data presented here is from all participants that completed the assessment. | Posted | Mean | Standard Deviation | Kcalories | Average change from baseline to end of treatment (Kcalories at week 12 - week 0) |
|
|
|
|
| Secondary | Change in Stress Score | Stress, measured as total summed score on the 14-item Perceived Stress Scale, with higher scores indicating greater subjective stress. A negative change indicates lower stress with treatment. The Perceived Stress Scale (PSS)-14 has a total score range of 0 to 56, with individual items scored from 0 ("Never") to 4 ("Very often") and positively worded items reverse-scored before summing. | Data presented here is from all participants that completed the assessment. | Posted | Mean | Standard Deviation | score | Average change in stress score from week 0 to end of treatment week 12 (Week 12 - Week 0) |
|
|
|
|
| Other Pre-specified | Change in Weight | Percent change in Weight in kilograms will be assessed using a bioimpedance scale. higher negative score indicates greater change with treatment. | Posted | Mean | Standard Deviation | percent change | Average Weight Change from baseline week 0 to end of treatment week 12 (Week 12 - week 0) |
|
|
|
|
| 0 |
| 48 |
| 1 |
| 48 |
| 39 |
| 48 |
| EG001 | Placebo | Placebo pen administered weekly over 12 weeks Placebo: Placebo - administered once weekly for a total of 12 weeks | 0 | 48 | 0 | 48 | 32 | 48 |
|
| Bloating/Gas | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation/Hard Stools | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophogeal Reflux | Gastrointestinal disorders | Systematic Assessment |
|
| Lack/Loss of Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Injection Site Reaction | General disorders | Systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache/Migraine | Nervous system disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sore Throat/Throat Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |