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Beta-3 Adrenergic Receptor Agonist
Metabolic Rate Enhancers for Obesity Management
Phase 2
Recruiting
Led By Kong Y Chen, Ph.D.
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males between the age 18-35 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 1: days 1-17 cohorts 2: six one-day overnight inpatient stays over a six to twelve week period. cohort 3: four one-day overnight inpatient stays over a 12-week period.
Awards & highlights
Study Summary
This trial is testing how well different drugs work in increasing the body's basal metabolic rate in order to help treat obesity.
Who is the study for?
Healthy, lean men aged 18-35 can join this study. They must not smoke, have a stable weight without being athletes, and no history of serious health issues like cancer or liver disease. They should not be on medications that affect the trial drugs and must commit to the study schedule.Check my eligibility
What is being tested?
The trial is exploring how our bodies burn calories at rest and when cold but not shivering. It's testing various drugs' effects on metabolism including Naltrexone, Mirabegron (two doses), Topiramate with Phentermine (Qysmia), Propranolol, Pindolol, Dantrolene, Magnesium Sulfate, Caffeine and placebos.See study design
What are the potential side effects?
Possible side effects may include digestive discomfort from some drugs; caffeine could cause jitteriness or insomnia; beta-blockers like Propranolol might lead to fatigue or slow heart rate; Qysmia may cause dry mouth or tingling in limbs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged between 18 and 35.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort 1: days 1-17 cohorts 2: six one-day overnight inpatient stays over a six to twelve week period. cohort 3: four one-day overnight inpatient stays over a 12-week period.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 1: days 1-17 cohorts 2: six one-day overnight inpatient stays over a six to twelve week period. cohort 3: four one-day overnight inpatient stays over a 12-week period.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
BAT activity (Cohort 3 only)
Basal metabolic rate
Resting Energy Expenditure at low temperature
Side effects data
From 2014 Phase 4 trial • 13 Patients • NCT0188693738%
dry mouth
38%
decreased appetite
23%
difficulty sleeping
23%
constipation
15%
lightheaded upon standing
15%
increased urination
15%
headache
15%
nausea
15%
trouble concentrating
15%
tremor
15%
dizziness
8%
sour taste
8%
feeling drowsy or sleepy
100%
80%
60%
40%
20%
0%
Study treatment Arm
37.5 mg Phentermine
Placebo
Trial Design
4Treatment groups
Experimental Treatment
Group I: Low Temperature 2ndExperimental Treatment5 Interventions
Low temperature after 27c (Cohort 1 only)
Group II: Low Temperature 1stExperimental Treatment5 Interventions
Low temperature before 27c (Cohort 1 only)
Group III: Cohort 3Experimental Treatment3 Interventions
Interventions, in random order, will be administered during one of the four overnight inpatient stays
Group IV: Cohort 2Experimental Treatment6 Interventions
Interventions, in random order, will be administered during one of the six one-day stays
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naltrexone
2005
Completed Phase 4
~2420
Phentermine
2017
Completed Phase 4
~1360
Topiramate
2013
Completed Phase 4
~3400
Mirabegron 50mg
2023
Completed Phase 1
~40
Propranolol
2010
Completed Phase 4
~1290
Pindolol
2001
Completed Phase 2
~50
Dantrolene
2007
Completed Phase 2
~50
Magnesium Sulfate
2011
Completed Phase 4
~5160
Caffeine
2014
Completed Phase 3
~2980
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,314,457 Total Patients Enrolled
Kong Y Chen, Ph.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
10 Previous Clinical Trials
2,519 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a significant change in weight (more than 5 percent) in the past 6 months or you are a trained athlete.I am currently using products that change how my body uses energy.You currently smoke cigarettes or use other tobacco products.My thyroid levels have been abnormal, but not seriously according to my doctor.My kidneys are not working well, with a creatinine clearance of 50 mL/min or less.I have had cancer or weight-loss surgery in the past.I have diabetes or my blood sugar level is above 126 mg/dL when fasting.Your weight in relation to your height is either too low or too high.You drink more than 4 cups of coffee per day and experience withdrawal symptoms when you don't have caffeine.The investigator believes there are other factors that could make it hard to understand the study results.I have liver disease or my ALT levels are more than twice the normal limit.You are in good overall health.I do not have psychological conditions like claustrophobia or depression that would prevent my safe participation.I have not had excessive radiation exposure from medical tests in the past year.My current medications won't interfere with the study drugs.I have a history of heart problems.I am diagnosed with bladder outlet obstruction or I'm taking medication for an overactive bladder.I am a man aged between 18 and 35.I have a history of asthma, COPD, or glaucoma.You have had bad reactions or allergies to the study drugs in the past.My blood pressure is over 140/90 mmHg or I am on medication for high blood pressure.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 3
- Group 3: Low Temperature 1st
- Group 4: Low Temperature 2nd
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible for participation in this clinical investigation?
"To be considered for this clinical trial, volunteers must demonstrate healthy subject status and fall within the ages of 18 to 35. The study is attempting to enroll a total of 134 individuals."
Answered by AI
Is this trial presently accepting participants?
"According to the information published on clinicaltrials.gov, this medical study is actively recruiting participants since its inception date of February 7th 2014 and most recent update from September 7th 2022."
Answered by AI
Has Phentermine received the green light from the FDA?
"Despite being in the second phase of testing, there is sufficient evidence to assign a safety rating of 2 for Phentermine as no data currently supports its efficacy."
Answered by AI
How many volunteers are participating in this medical experiment?
"Indeed, the information on clinicaltrials.gov alludes to this study's active status. It was initially uploaded on February 7th 2014 and last revised September 7th 2022. The medical trial requires a total of 134 individuals across two sites for enrollment purposes."
Answered by AI
Does this study accommodate elderly participants?
"This trial has an age restriction of 18 to 35 years old; yet, there are 87 studies available for participants below the legal age and 471 clinical trials accessible to those above 65."
Answered by AI
To what ailment is Phentermine frequently prescribed?
"Phentermine is a commonly prescribed medication for treating angina pectoris. In some cases, it can also help with conditions like multiple sclerosis, pain and catarrh."
Answered by AI
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