Nimacimab and Nimacimab + Semaglutide for Obesity
(CBeyond Trial)
Recruiting in Palo Alto (17 mi)
+18 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Skye Bioscience, Inc.
Must not be taking: Corticosteroids, GLP-1 agonists
Disqualifiers: Diabetes, Obesity surgery, Renal impairment, others
Prior Safety Data
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.
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.
12345How 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.
12367Eligibility 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)
+8 more
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
+22 more
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Semaglutide injection + Nimacimab injection 200 mgExperimental Treatment2 Interventions
Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg
Group II: Nimacimab injectionExperimental Treatment1 Intervention
Nimacimab injection 200 mg
Group III: Semaglutide injection + Nimacimab placebo injectionActive Control2 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 injectionPlacebo Group1 Intervention
Matching nimacimab placebo injection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
ActivMed Practices & ResearchPortsmouth, NH
L-MARC Research CenterLouisville, KY
Principal InvestigatorLouisville, KY
Charlottesville Medical ResearchCharlottesville, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Skye Bioscience, Inc.Lead Sponsor
Bird Rock Bio Sub, Inc.Collaborator
References
Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]The treatment of obesity can no longer be reduced to a simplistic view of weight loss. Metabolic adaptation leads to systematic weight regain following weight-loss efforts, and new obesity treatments should therefore aim to induce long-standing double-digit weight loss, and thus improve and even reverse obesity-associated comorbidities such as type 2 diabetes. Until now, only metabolic surgery has been able to achieve such a goal, but this invasive procedure cannot be offered on a large scale. Among the alternatives, lifestyle interventions and drug therapies have often been disappointing. The recent availability of once-weekly subcutaneous 2.4 mg semaglutide (a glucagon-like peptide-1 receptor agonist; Wegovy™ Novo Nordisk A/S, Bagsværd, Denmark) has changed the scene, and semaglutide is considered a 'game changer' in the treatment of obesity. The results from the phase III STEP (Semaglutide treatment effect in people with obesity) clinical programme have shown that semaglutide provides clinically meaningful and sustained weight loss in ranges much higher than those achieved with previously available pharmacotherapies. These results led to the approval of semaglutide by regulatory authorities as an adjunct to a reduced-calorie diet and increased physical activity in people with obesity or overweight, with at least one weight-related comorbidity. With data from phase II and III clinical trials showing that newer drugs (i.e. the glucagon-like peptide-1 and gastric inhibitory polypeptide dual receptor agonist tirzepatide and the amylin agonist cagrilintide, either alone or combined) produce a greater sustained weight loss than semaglutide, an upstream 'weight-centric' strategy has emerged as a new standard for the treatment of type 2 diabetes.
Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. [2023]Cardiovascular disease is the most common cause of morbidity and mortality worldwide, and the risk is heightened in the presence of obesity. We review semaglutide, a drug recently approved for chronic weight management in adults with obesity or who are overweight.
Impact of BMI and comorbidities on efficacy of once-weekly semaglutide: Post hoc analyses of the STEP 1 randomized trial. [2023]This study assessed the effects of semaglutide on body weight, cardiometabolic risk factors, and glycemic status in individuals categorized by baseline BMI with or without additional obesity-related comorbidities, including prediabetes and high risk of cardiovascular disease (CVD).
Next Generation Antiobesity Medications: Setmelanotide, Semaglutide, Tirzepatide and Bimagrumab: What do They Mean for Clinical Practice? [2021]There is a new generation of antiobesity drugs in development or just arriving on the scene. First, setmelanotide has been approved for three of the ultrarare genetic conditions that cause obesity-pro-opiomelanocortin deficiency, proprotein convertase subtilisin and kexin type 1 (an important enzyme in the melanocortin pathway) and leptin receptor deficiency. Setmelanotide marks the first in a personalized medicine approach to obesity. Second, semaglutide 2.4 mg once weekly has been submitted to regulators in the United States and the European Union for approval for patients with obesity (body mass index [BMI] ≥30 kg/m2) or overweight (BMI ≥27 kg/m2) and at least one weight related comorbidity. This drug has been studied in five phase 3 clinical trials, four discussed herein: semaglutide produces roughly twice as much weight loss as we have seen in older antiobesity medications. Semaglutide is already in use for treatment of diabetes and, as a glucagon-like peptide 1 (GLP-1) receptor analog, is part of a class of drugs used widely in diabetes. Tirzepatide, a glucose-insulin peptide and GLP-1 dual agonist is in phase 3 study for obesity management, and bimagrumab is a new agent in phase 2 with a unique mechanism of action; they are generating much interest. The purpose of this narrative review is lay the groundwork for a discussion of the clinical impact of these new medications on the clinical practice of obesity. Further, these developments shall be used to launch a speculation of what is likely to be their impact on the future of obesity pharmacotherapy.
Efficacy and Safety of Liraglutide and Semaglutide on Weight Loss in People with Obesity or Overweight: A Systematic Review. [2022]The effect and safety of Semaglutide and Liraglutide on weight loss in people with obesity or overweight were evaluated by a Network Meta-Analysis system to provide an evidence-based reference for clinical treatment.
[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]Semaglutide (Ozempic®) is a new once-weekly agonist of glucagon-like peptide-1 receptors (GLP-1 AR) indicated in the treatment of type 2 diabetes (T2D). Phase III clinical trials of the SUSTAIN programme demonstrated both the efficacy and safety of semaglutide in patients with T2D treated by diet and exercise, oral antidiabetic agents or even insulin. Direct and indirect comparative clinical trials showed that semaglutide (subcutaneous 0.5 or 1.0 mg once weekly) exerts a better glucose-lowering activity and a greater weight loss than other GLP-1 AR. Presented as prefilled pens for subcutaneous injection, semaglutide is currently reimbursed in Belgium after failure of antidiabetic therapy including metformin (HbA1c superior to 7,5 % or 58 mmol/mol) in T2D patients with body mass index ? 30 kg/m².
Semaglutide: First Global Approval. [2019]Novo Nordisk has developed a subcutaneous formulation of semaglutide (Ozempic®), a modified human glucagon-like peptide-1 (GLP-1) analogue, for the treatment of type 2 diabetes mellitus. It has been developed using Novo Nordisk's proprietary protein-acylation technology, and is administered using an injection device. Semaglutide lowers blood glucose by stimulating the release of insulin and also lowers body weight. Once-weekly subcutaneous semaglutide has recently been approved in the US, Puerto Rico and Canada, and has received a positive opinion in the EU for the treatment of patients with type 2 diabetes. It will be launched as the Ozempic® Pen, a pre-filled device. Semaglutide is also under regulatory review in Japan and Switzerland for the treatment of type 2 diabetes. Clinical development for obesity, non-alcoholic steatohepatitis and non-alcoholic fatty liver disease is underway worldwide. This article summarizes the milestones in the development of semaglutide leading to this first approval for type 2 diabetes.