Nimacimab and Nimacimab + Semaglutide for Obesity

(CBeyond Trial)

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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a proof-of-concept study to assess the safety and efficacy of Nimacimab Injection compared to an active and placebo injection control.

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.

What data supports the effectiveness of the drug Nimacimab and Nimacimab + Semaglutide for obesity?

Research shows that Semaglutide, a component of the treatment, is effective for weight loss in people with obesity, providing significant and sustained weight reduction. It has been approved for chronic weight management and is considered a 'game changer' in obesity treatment. ^{1 2 3 4 5}

What data supports the effectiveness of the drug Semaglutide for obesity?

Research shows that Semaglutide, a drug used for weight management, has been effective in providing significant and sustained weight loss in people with obesity. It is considered a 'game changer' because it achieves greater weight loss than older medications and has been approved for use alongside a reduced-calorie diet and increased physical activity. ^{1 2 3 4 5}

How is the drug Nimacimab and Nimacimab + Semaglutide unique for treating obesity?

This treatment is unique because it combines Nimacimab with Semaglutide, a drug known for its effectiveness in achieving significant and sustained weight loss, which is more than what previous obesity medications have achieved. Semaglutide is a once-weekly injection that not only helps with weight loss but also improves related health issues like type 2 diabetes and cardiovascular risks. ^{1 2 3 6 7}

How is the drug Nimacimab and Nimacimab + Semaglutide unique for treating obesity?

The combination of Nimacimab and Semaglutide for obesity is unique because Semaglutide, a glucagon-like peptide-1 receptor agonist, has shown significant and sustained weight loss effects, which are much higher than those achieved with previous drugs. This makes it a 'game changer' in obesity treatment, offering an alternative to more invasive procedures like metabolic surgery. ^{1 2 3 6 7}

Research Team

Chief Development Officer

Principal Investigator

Skye Bioscience, Inc.

Eligibility Criteria

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

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

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

Exclusion Criteria

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

Platelets ≤ 120 × 109/L

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]

3. United States 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. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Liraglutide and Semaglutide on Weight Loss in People with Obesity or Overweight: A Systematic Review. [2022]

6. Belgium pubmed.ncbi.nlm.nih.gov

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

7. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. [2019]