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Monoclonal Antibodies

Nimacimab and Nimacimab + Semaglutide for Obesity (CBeyond Trial)

Phase 2
Recruiting
Research Sponsored by Skye Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If on hormone replacement therapy, must be on a stable dose for at least 3 months prior to screening, including use of thyroxine
Agreement in male participants to not donate sperm from screening throughout the study and for at least 90 days after the last dose of study drug
Must not have
Known malignancy that is progressing or has required active treatment within the past 3 years prior to screening
Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, 24 and 34
Awards & highlights

Summary

This trial will test whether Nimacimab Injection is safe and effective compared to other injections.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects were not detailed; however, common reactions to injections may include pain at the injection site, swelling, redness, and possible systemic effects depending on how the body reacts to Nimacimab and Semaglutide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the same dose of hormone therapy, including thyroxine, for at least 3 months.
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I agree not to donate sperm during and for 90 days after the study.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a cancer that has worsened or needed treatment in the last 3 years.
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I am not pregnant, breastfeeding, nor planning to become pregnant during the study.
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My heart condition is not stable.
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I have been diagnosed with diabetes.
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I have allergies or have been exposed to specific medications.
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My hemoglobin level is below the normal range for my gender.
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I have had or am planning to have surgery for weight loss.
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My kidney function is significantly reduced.
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I have had an organ or bone marrow transplant.
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I have a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, 24 and 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, 24 and 34 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AEs including SAEs and AEs of special interest
Percent change in body weight
Secondary study objectives
Change in body composition
Change in waist circumference
Other study objectives
Change in lean versus fat mass ratio
Sleep stage quantification

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
semaglutide injection
2022
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

Skye Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
56 Total Patients Enrolled
Bird Rock Bio Sub, Inc.UNKNOWN
Chief Development OfficerStudy DirectorSkye Bioscience, Inc.
1 Previous Clinical Trials
204 Total Patients Enrolled
~80 spots leftby Aug 2025
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