Nimacimab and Nimacimab + Semaglutide for Obesity

(CBeyond Trial)

Not currently recruiting at 18 trial locations

Overseen By Joseph Soufer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Skye Bioscience, Inc.

Must not be taking: Antidepressants, GLP-1 agonists

Disqualifiers: Diabetes, Obesity surgery, Drug abuse, others

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

Compensation: Varies

Number of Visits: 35

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Nimacimab (an experimental treatment) alone or combined with Semaglutide (a medication for weight management) can safely and effectively treat obesity. The study compares these treatments against a placebo to evaluate their effectiveness in reducing weight. Participants should have a high Body Mass Index (BMI) of 30 or more, or a BMI between 27 and 30 with certain weight-related health issues, such as high cholesterol or sleep apnea. Individuals with a stable weight and no diabetes diagnosis might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on cardiovascular, anti-hypertensive, or anti-depressant medications, you must be on a stable dose for at least 3 months before joining the trial.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on cardiovascular or anti-hypertensive medications, you must be on a stable dose for at least 3 months before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Nimacimab is generally safe. In a previous study, participants tolerated Nimacimab 200 mg well, experiencing side effects similar to those of a placebo, indicating it did not cause more issues than a sugar pill. No serious mental health side effects were reported, and it was gentle on the stomach.

When combined with Semaglutide, patients continued to respond well to Nimacimab. Although the primary goal was weight loss, safety remained a major focus. The combination did not introduce significant new side effects compared to each drug alone.

Semaglutide is already approved for other uses and is known for its safety. It is usually well-tolerated, with mild nausea being the most common side effect.

Overall, both Nimacimab and its combination with Semaglutide appear safe based on previous studies. However, joining a clinical trial always involves some risk, so discussing these with the research team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Nimacimab and its combination with Semaglutide for treating obesity because these treatments offer something new compared to current options. Unlike standard treatments, which often focus on appetite suppression or metabolic rate increase, Nimacimab introduces a novel mechanism by targeting specific pathways in the immune system to potentially influence weight regulation. The combination with Semaglutide, a well-known GLP-1 receptor agonist, could enhance weight loss effects more effectively than using Semaglutide alone. This dual approach aims to provide a more comprehensive solution to obesity, offering hope for better outcomes in managing weight.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that nimacimab alone did not result in significant weight loss in earlier studies, as it only caused a small drop in weight compared to a placebo. In this trial, some participants will receive nimacimab alone, while others will receive a combination of nimacimab and semaglutide. Previous studies found more promising results when nimacimab was combined with semaglutide. This combination led to about 30% more weight loss than using semaglutide alone and helped prevent weight regain, a common issue in weight management. These findings suggest that using nimacimab and semaglutide together could be more effective for weight loss than using either one alone. ^{1 3 4 6 7}

Who Is on the Research Team?

Chief Development Officer

Principal Investigator

Skye Bioscience, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals who are struggling with obesity. Specific eligibility criteria details were not provided, so participants should inquire about the inclusion and exclusion requirements directly from the study organizers.

Inclusion Criteria

Have an HbA1c < 48 mmol/mol (6.5%) at screening

Have had a stable body weight for the 3 months prior to screening (no more than 5% body weight gain and/or loss)

I am a man who agrees to use contraception and not donate sperm.

Exclusion Criteria

Have PHQ-9 score ≥ 15 at screening and/or Day 0

At Day 0 have any suicidal ideation of type 4 or 5 on the C-SSRS in the previous month or any suicidal behavior in the previous month

AST or ALT > 3 × ULN at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive once weekly doses of Nimacimab Injection, placebo, or Nimacimab co-administered with Semaglutide Injection

26 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at week 34 and week 38 (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Nimacimab
• Semaglutide

Trial Overview

The study is testing the safety and effectiveness of a new treatment for obesity involving weekly injections of Nimacimab alone or in combination with Semaglutide, compared to a placebo injection.

How Is the Trial Designed?

Group I: Semaglutide injection + Nimacimab injection 200 mg Experimental Treatment 2 Interventions

Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg

Group II: Nimacimab injection Experimental Treatment 1 Intervention

Nimacimab injection 200 mg

Group III: Semaglutide injection + Nimacimab placebo injection Active Control 2 Interventions

Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection matching placebo injection

Group IV: Nimacimab placebo injection Placebo Group 1 Intervention

Matching nimacimab placebo injection

Who Is Running the Clinical Trial?

Skye Bioscience, Inc.

Lead Sponsor

Trials

2

Recruited

180+

Bird Rock Bio Sub, Inc.

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

Semaglutide 2.4mg was found to be the most effective treatment for weight loss in people with obesity, resulting in an average loss of 12.47 kg, and also significantly reduced HbA1c levels compared to placebo.

While semaglutide 2.4mg showed the best efficacy, it also had the highest incidence of adverse events, including hypoglycemia, indicating a trade-off between effectiveness and safety compared to liraglutide treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Liraglutide and Semaglutide on Weight Loss in People with Obesity or Overweight: A Systematic Review. Xie, Z., Yang, S., Deng, W., et al.[2022]

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]

In a study involving participants with a BMI of 27 kg/m² or higher, semaglutide led to significant weight loss of -16.2% for those with a BMI <35 and -14.0% for those with a BMI ≥35 after 68 weeks, both significantly better than placebo.

Semaglutide also positively impacted cardiometabolic risk factors across all subgroups, including those with obesity-related comorbidities like prediabetes and high cardiovascular disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. McGowan, BM., Houshmand-Oeregaard, A., Laursen, PN., et al.[2023]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

Setmelanotide has been approved for treating specific genetic conditions that cause obesity, representing a significant step in personalized medicine for obesity management.

Semaglutide, which has shown to produce approximately twice the weight loss compared to older antiobesity medications, is under regulatory review for treating obesity and is already used for diabetes, highlighting its dual efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next Generation Antiobesity Medications: Setmelanotide, Semaglutide, Tirzepatide and Bimagrumab: What do They Mean for Clinical Practice? Ryan, DH.[2021]

Citations

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Skye Bioscience Reports Topline CBeyond™ Phase 2a ...

In the monotherapy arm, nimacimab 200 mg did not achieve the primary endpoint, with placebo-subtracted weight loss of -1.26% at week 26 (p= ...

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Skye's shares crash down to earth on Phase II obesity loss

Though nimacimab failed to trigger weight loss as a monotherapy, analysts are intrigued by the drug's activity alongside GLP-1RA Wegovy.

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The trial's results show that nimacimab combined with semaglutide significantly reduced weight regain compared to semaglutide alone (18.1% ...

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The trial is evaluating nimacimab, the company's peripherally restricted CB1 inhibitor antibody, as a potential treatment for obesity and ...