Semaglutide Injectable Product for Obesity

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Case Western Reserve University, Cleveland, OH
Obesity+2 More
Semaglutide Injectable Product - Drug
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a drug may help reduce fat and inflammation in people with HIV.

See full description

Eligible Conditions

  • Obesity
  • Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)
  • Lipohypertrophy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Semaglutide Injectable Product will improve 4 primary outcomes, 9 secondary outcomes, and 2 other outcomes in patients with Obesity. Measurement will happen over the course of 56 weeks.

56 weeks
Adipokines and natriuretic peptides
Changes in EndoPat
Changes in amount of fat by DXA scan
Changes in epicardial fat
Changes in glucose metabolism
Changes in gut hormones
Changes in gut integrity
Changes in inflammation
Changes in insulin sensitivity
Changes in liver fat
Changes in pulse wave velocity
Changes in resting energy expenditure
Changes in subcutaneous abdominal fat
Changes in visceral abdominal fat
Changes over time in HIV-associated lipohypertrophy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Participants with HIV and lipohypertrophy: semaglutide arm
1 of 2
Participants with HIV and lipohypertrophy: placebo arm
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 104 total participants across 2 different treatment groups

This trial involves 2 different treatments. Semaglutide Injectable Product is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Participants with HIV and lipohypertrophy: semaglutide arm
Drug
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
Participants with HIV and lipohypertrophy: placebo arm
Drug
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 56 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 56 weeks for reporting.

Who is running the study

Principal Investigator
A. E.
Allison Eckard, Multiple Principal Investigator
Medical University of South Carolina

Closest Location

Case Western Reserve University - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.
HIV-1 RNA <400 copies/mL for ≥6 months.
Male or female, aged ≥18 years.
HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
Body mass index ≥25 kg/m2.
Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.
Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.
Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.
Stated willingness to comply with all study procedures and availability for the duration of the study.
All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35 mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered of child-bearing potential.

Patient Q&A Section

What causes obesity?

"Overweight individuals generally have a higher risk of developing non-communicable diseases such as diabetes, heart disease and osteoarthritis. Obesity increases the risk of developing diabetes, and it causes high blood pressure and increases the risk of developing cardiovascular diseases such as ischemic heart disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of obesity?

"Obesity is defined by a BMI at or above > or=30 kg/m(2) in men or > or =27 kg/m(2) or > or =26 kg/m(2) in women. The signs of obesity are swelling of the face and neck (a adipose facies), high blood pressure, high cholesterol, and high blood sugar levels. People with signs of obesity should be evaluated with a cardiologist for liposuction and diet counselling." - Anonymous Online Contributor

Unverified Answer

What is obesity?

"Obesity (defined as a BMI ≥30 kg/m) is a common condition that influences both short-term and long-term health. There is no single disease entity associated with obesity." - Anonymous Online Contributor

Unverified Answer

What are common treatments for obesity?

"The mainstay of obesity treatment seems to be behavioral modification and exercise. There are no prescription drugs approved for the treatment of obesity. There is limited research on the effectiveness of cognitive behavioral therapy for obesity. It is a plausible treatment option because it is safe and effective. At least one prescription drug, sibutramine, approved by the United States Food and Drug Administration is available. Because of concerns of cardiovascular side-effect, this drug is not ideal for everyone. In general, behavioral weight loss and exercise treatment are effective methods that will not only make the patients feel better, but will also help them maintain overall health." - Anonymous Online Contributor

Unverified Answer

How many people get obesity a year in the United States?

"Approximately 35.0%, or approximately 74.4 million adults, will be overweight by 2022. More than 9.4%, or approximately 22.4% of adults, will be obese by 2022." - Anonymous Online Contributor

Unverified Answer

Can obesity be cured?

"Obesity should be managed as early as possible, with weight loss being the best method to prevent or reduce the incidence of future cancer. Obesity and cancer are more common when the body mass increases as the result of a low body mass or cachexia." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating obesity?

"There have been new discoveries for treating obesity. There has been research on finding chemicals in foods that may prevent the body from storing fats and getting rid of carbohydrates that build up. And there has been research on finding a certain bacterium that could digest and break down the body's own fat stores without being harmful. Research has found that many of these bacteria are found in small amounts in many common foods. Some of these bacteria are found in foods like beans, soy, tomatoes and other vegetables. And research showed that these bacteria may be beneficial to treat obesity because they break down body fats, but they could also cause diarrhea." - Anonymous Online Contributor

Unverified Answer

Is semaglutide injectable product typically used in combination with any other treatments?

"The use of the semaglutide product was not associated with any additional or increased utilization for other indications. Although no statistically significant difference was presented for utilization of semaglutide and metformin, other medications could be significantly affected by semaglutide use. This is an observational study; as such, no causal conclusions can be drawn from this data." - Anonymous Online Contributor

Unverified Answer

What is the latest research for obesity?

"Obesity has a huge impact upon health worldwide especially for the developing countries. The prevalence has reached alarming proportions when compared to the previous years where the mean BMI has decreased significantly in the western countries. This rapid change was the cause of different researchers and scientists working in many parts of the world especially in the developing countries. Furthermore, the obese population represents a group of patients that have many unique challenges when managing their disease as well as the problems when living a healthy lifestyle. Obesity is an important issue that needs further investigation for understanding the underlying mechanisms linking obesity to different disease pathologies such as diabetes, ischaemic heart disease, cancer, inflammatory diseases and some neurological disorders." - Anonymous Online Contributor

Unverified Answer

Does obesity run in families?

"Results from a recent clinical trial contradict most of the existing studies about obesity being either a genetic or environmental disease. To our knowledge, this is the first time that the authors' data is used to study the impact of familial factors in an effort to determine the genetic component of obesity. Results from a recent clinical trial suggest that there are at least two possible scenarios: the genetic and the environmental factors could act on the same people at the same time. If our data is true, then obesity could be considered a multifactorial disease. If that is what we saw in our data, then we are back to a new view of the disease and the new possibility of treating it. We look forward to further studying this relationship using the same data in new studies." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of obesity?

"Obesity is a multifactorial condition with multiple causes, but it is primarily a function of a predisposition to increased adiposity and less physical activity, which may be the consequence of lifestyle factors including social inequality." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving semaglutide injectable product?

"Based on these data, semaglutide showed potential to improve cardiovascular risk factors and a reduction in the progression of atherosclerosis in patients with type 2 diabetes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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