Weight Management for Obesity and Kidney Disease

Overseen By Heather LaPier, BSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Western University, Canada

Must not be taking: Semaglutide, Liraglutide, Dulaglutide

Disqualifiers: Type 1 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a weight management program using semaglutide, a medication that may aid weight loss. The researchers aim to determine if this approach can help individuals with obesity and serious kidney problems, such as those on dialysis, lose weight to improve their chances of receiving a kidney transplant. Participants will either join a virtual program with semaglutide and coaching or continue their regular care. The trial seeks adults with a BMI over 35 who have significant kidney issues or are on dialysis. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using more than the starting dose of certain medications like semaglutide, liraglutide, or dulaglutide.

What is the safety track record for these treatments?

Research has shown that semaglutide is generally safe for individuals with kidney issues and obesity. One study reported fewer serious side effects in those taking semaglutide compared to those not taking it (49.6% vs. 53.8%). Common side effects include nausea and stomach problems like diarrhea and belly pain, which are usually mild and improve over time.

Studies have also shown that virtual weight management coaching effectively aids weight loss, performing as well as in-person meetings. Participants in these programs often feel supported and achieve positive results.

This trial combines semaglutide and virtual coaching, both of which past research has shown to be safe and effective. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about semaglutide for obesity and kidney disease because it offers a dual-action approach. Unlike typical treatments that focus solely on controlling blood sugar or managing symptoms, semaglutide is a GLP-1 receptor agonist that not only helps with weight loss but also provides potential benefits for kidney health. Administered through a once-weekly injection, it combines medication with personalized nutritional and movement coaching, which could enhance its effectiveness compared to standard care. This holistic approach aims to address the root causes of obesity while also considering the unique needs of patients with kidney disease.

What evidence suggests that this trial's treatments could be effective for weight management in obesity and kidney disease?

Research has shown that semaglutide, which participants in this trial may receive as part of the Virtual Weight Management Program, can aid in weight loss and improve kidney health. One study found that semaglutide reduced major heart problems by 20% in people with obesity. It also lowers the risk of kidney issues and heart-related death in individuals with type 2 diabetes and chronic kidney disease (CKD). Virtual weight management programs, another component of this trial, include coaching and have been shown to help people lose more weight compared to those not using virtual care. Together, semaglutide and virtual coaching could effectively manage weight and support kidney health. ^{3 6 7 8 9}

Who Is on the Research Team?

Kristin K Clemens, MD, MSc

Principal Investigator

St. Joseph's Health Care London

Louise Moist

Principal Investigator

London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for individuals with obesity and high-risk chronic kidney disease (CKD) or those on dialysis, aiming to lose weight for a kidney transplant. Participants must be seeking to manage their weight and willing to engage in a virtual program.

Inclusion Criteria

I am at high risk for severe kidney failure or am on dialysis.

BMI > 35 kg/m^2

Exclusion Criteria

I do not have insurance coverage for semaglutide.

I have Type 1 diabetes.

I cannot have a kidney transplant due to health reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vanguard Phase

Feasibility study to ensure recruitment and process inclusivity, and assess program acceptability

12 months

Treatment

Participants receive either usual care or a virtual weight management program with semaglutide and coaching

26 weeks

Virtual coaching once every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide
• Virtual Weight Management Coaching

Trial Overview The OK-TRANSPLANT 2 study is testing the effectiveness of virtual weight management coaching compared to usual care practices. Additionally, it will evaluate the use of Semaglutide, a medication that may aid in weight loss.

How Is the Trial Designed?

Group I: Virtual Weight Management Program Experimental Treatment 2 Interventions

A maximum tolerated dose of semaglutide (Ozempic/Wegovy) will be administered once weekly subcutaneously, up to a dose of 2.0 mg. Participants will also receive nutritional and movement advice, as well as virtual coaching once every 4 weeks for 6 months.

Group II: Usual Care Active Control 1 Intervention

Usual care participants will continue to receive the typical standard of kidney and diabetes care. They will not receive any study medication or coaching.

Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in United States as Wegovy for:

• Obesity

Approved in United States as Rybelsus for:

• Type 2 diabetes

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Lawson Health Research Institute

Collaborator

Trials

684

Recruited

432,000+

Unity Health Toronto

Collaborator

Trials

572

Recruited

470,000+

Queen Elizabeth II Health Sciences Centre

Collaborator

Trials

26

Recruited

14,200+

St. Michael's Hospital (Toronto, Canada)

Collaborator

Trials

1

Recruited

60+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

668

Recruited

424,000+

St. Michael's Hospital (Toronto, Canada)

Collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Collaborator

Trials

678

Recruited

421,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Collaborator

Trials

686

Recruited

427,000+

Published Research Related to This Trial

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Subcutaneous semaglutide (Ozempic®), a GLP-1 receptor agonist, has shown significant efficacy in improving glycemic control and reducing HbA1c, albuminuria, and blood pressure in patients with advanced diabetic kidney disease (DKD) during a 6-month follow-up study involving patients on maintenance hemodialysis.

The treatment not only aids in weight loss and appetite suppression but also helps preserve residual kidney function, potentially improving patient outcomes and facilitating their inclusion on kidney transplant waiting lists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Semaglutide, a Glucagon-Like Peptide-1 Receptor Agonist in Real-Life: A Case Series of Patients in Maintenance Incremental Hemodialysis. De la Flor, JC., Lorenzo, JD., Marschall, A., et al.[2022]

In a study involving 486 type 2 diabetes patients, semaglutide was found to be effective in improving glycemic control and achieving weight loss, with no significant differences in efficacy between patients with chronic kidney disease (CKD) and those without.

The treatment was safe for all patients, and CKD severity did not notably affect the treatment response, suggesting that semaglutide can be effectively used in managing type 2 diabetes in patients with varying levels of kidney function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of chronic kidney disease and its severity on the efficacy of semaglutide in type 2 diabetes patients: a multicenter real-world study. García de Lucas, MD., Caballero, I., Fernández-García, JC., et al.[2023]

Two obese hemodialysis patients successfully lost weight using semaglutide, a GLP-1 receptor agonist, achieving a weight loss of 6.5 to 9.0 kg over 9 months, which is about 1 kg per month.

Semaglutide was well tolerated at a maximum dose of 1 mg/week, suggesting it could be a safe and effective alternative to bariatric surgery for weight management in patients with obesity and kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for treatment of obesity in hemodialysis patients waiting for a kidney transplant: new hope? Touzot, M., Ureña-Torres, P., Dupuy, O.[2022]

Oral semaglutide (Rybelsus®), a GLP-1 receptor agonist, not only helps lower blood sugar levels in people with type 2 diabetes but also promotes significant weight loss and has a lower risk of causing hypoglycemia.

Clinical studies indicate that GLP-1 receptor agonists are safe for individuals with type 2 diabetes and chronic kidney disease, and they may offer additional benefits such as protecting kidney function and reducing the risk of major cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peptide in a Pill - Oral Semaglutide in the Management of Type 2 Diabetes. Selvarajan, R., Subramanian, R.[2023]

In the STEP 2 trial involving 1,205 participants, semaglutide (both 1.0 mg and 2.4 mg) significantly improved kidney function as measured by urine albumin-to-creatinine ratio (UACR), with reductions of -14.8% and -20.6% respectively, compared to an increase of +18.3% in the placebo group.

Across pooled data from STEP 1-3, semaglutide did not affect estimated glomerular filtration rate (eGFR) decline in participants with normal kidney function, indicating its safety in terms of kidney function preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials. Heerspink, HJL., Apperloo, E., Davies, M., et al.[2023]

Sodium-glucose cotransporter type 2 (SGLT2) inhibitors provide cardiovascular and renal protection for patients with diabetic kidney disease, but there is still a high residual risk and limited effectiveness in moderate to severe chronic kidney disease (CKD).

Oral semaglutide, a GLP-1 receptor agonist, offers a promising alternative with potent antihyperglycemic effects, low risk of hypoglycemia, and cardiovascular and renal benefits, potentially improving early treatment options for patients with type 2 diabetes and diabetic kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucagon-like peptide 1(GLP-1) receptor agonists in the management of the patient with type 2diabetes mellitus and chronic kidney disease: an approach for the nephrologist. Cases, A.[2023]

In a post-hoc analysis of 8416 patients with type 2 diabetes from multiple trials, semaglutide initially caused a decline in estimated glomerular filtration rate (eGFR), but this decline plateaued over time, indicating no long-term adverse effects on kidney function compared to placebo.

Semaglutide significantly reduced urinary albumin-to-creatinine ratio (UACR), suggesting improved kidney health, and there was no increase in kidney-related adverse events compared to other treatments, highlighting its safety and efficacy in managing kidney function in diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of once-weekly subcutaneous semaglutide on kidney function and safety in patients with type 2 diabetes: a post-hoc analysis of the SUSTAIN 1-7 randomised controlled trials. Mann, JFE., Hansen, T., Idorn, T., et al.[2020]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Semaglutide, marketed as Rybelsus, is the first oral glucagon-like peptide receptor agonist approved by the FDA in 2019 for treating type 2 diabetes, highlighting its innovative delivery method.

This medication, taken once daily, aids in glucose control and weight management, potentially leading to improved health outcomes for individuals with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide Is a New Once-Daily Oral Medication to Treat Type 2 Diabetes. Blakely, KK., Weaver, K.[2021]

Citations

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Effects of Semaglutide on Chronic Kidney Disease in ... Semaglutide reduced the risk of clinically important kidney outcomes and death from cardiovascular causes in patients with type 2 diabetes and chronic kidney ...

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Long-term kidney outcomes of semaglutide in obesity and ... The SELECT trial previously reported a 20% reduction in major adverse cardiovascular events with semaglutide (n = 8,803) versus placebo (n ...

4. academic.oup.com academic.oup.com/ckj/article/18/8/sfaf227/8196614

Effects of oral semaglutide on kidney outcomes in people with ... Subcutaneous semaglutide has shown kidney-protective effects in people with type 2 diabetes (PWT2D), but data on oral semaglutide remain limited ...

5. ajkd.org ajkd.org/article/S0272-6386%2824%2900975-2/fulltext

Glucagon-like Peptide-1 Receptor Agonists: New Evidence ... The analysis reported a 24% reduction in the primary endpoint in those who had received semaglutide versus placebo and a 21% reduction in the ...

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The Use of Semaglutide in Patients With Renal Failure-A ... The results of this retrospective review of the EMR of patients with CKD and obesity indicate that semaglutide had acceptable safety in patients with CKD 4 or ...

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a randomized double-blind placebo-controlled clinical trial Semaglutide treatment for 24 weeks resulted in a clinically meaningful reduction in albuminuria in patients with overweight/obesity and non-diabetic CKD.

8. fda.gov fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

FDA's Concerns with Unapproved GLP-1 Drugs Used for ... FDA is aware of fraudulent compounded semaglutide and tirzepatide marketed in the U.S. that contain false information on the product label. In ...

9. novomedlink.com novomedlink.com/diabetes/products/treatments/rybelsus/efficacy-safety/safety-data.html

Safety data from RYBELSUS ® (semaglutide) clinical trials The most frequently reported adverse reactions were GI disorders, including nausea, abdominal pain, and diarrhea; Nausea, vomiting, and/or diarrhea occurred ...