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ObesityPhase 2CBeyondNCT06577090

Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo

A Phase 2 study testing Nimacimab injection, semaglutide injection and Nimacimab 300 mg injection in people with Obesity, run by Skye Bioscience, Inc. at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity
What is being tested?
Nimacimab injection, semaglutide injection and Nimacimab 300 mg injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
16 sitesUnited States
Study dates
22 Aug 2024to 28 Feb 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place to 65 years, inclusive, at the time of signing the informed consent.
  • Male, female, and/or nonbinary participants.
  • Have Body Mass Index (BMI) of
  • ≥ 30 kg/m2 to ≤ 45 kg/m2 OR
  • ≥ 27 kg/m2 and < 30 kg/m2 with clinically confirmed diagnosis of at least 1 of the following weight-related co-morbidities:
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  • dyslipidemia: on lipid-lowering medication or having low-density lipoprotein (LDL) ≥ 160 mg/dL (4.1 mmol/L) or triglycerides ≥ 150 mg/dL (1.7 mmol/L) or high-density lipoprotein (HDL) < 40 mg/dL (1.0 mmol/L) for men or HDL < 50 mg/dL (1.3 mmol/L) for women at screening.
  • cardiovascular disease: (for example, ischemic cardiovascular disease, New York Heart Association [NYHA] Functional Classification Class I-II heart failure).
  • obstructive sleep apnea syndrome (Salzano 2021).
  • controlled arterial hypertension with systolic blood pressure (SBP) < 150 mmHg or diastolic blood pressure (DBP) < 90 mmHg.
  • Have an HbA1c <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).
  • If on cardiovascular, anti-hypertensive, must be controlled controlled on a stable dose for 3 months prior to randomization.
  • If on hormone replacement therapy, must be on a stable dose for at least 3 months prior to screening, including use of thyroxine.
  • Females of childbearing potential must agree:
  • to use an approved method of contraception from screening throughout the study and for at least 90 days after the last dose of study drug.
  • to not donate ova from screening throughout the study and for at least 90 days after the last dose of study drug.
  • have a negative pregnancy test at screening and Day 0.
  • Male participants who are (hetero) sexually active must agree that he and his partner will each use an approved method of contraception from screening throughout the study and for at least 90 days after the last dose of study drug.
  • 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.

Who cannot join

  • Have any prior diagnosis of type 1 or type 2 diabetes mellitus (T1DM or T2DM, or rare forms of diabetes mellitus).
  • Have at least 1 laboratory value suggestive of diabetes during screening, including 1 or more of HbA1c ≥ 6.5% (48 mmol/mol), fasting serum glucose ≥ 126 mg/dL (7.0 mmol/L), or random glucose ≥ 200 mg/dL (11.1 mmol/L).
  • Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed > 1 year prior to screening).
  • Have obesity induced by other disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome) or use of systemic corticosteroids or uncontrolled hypothyroidism. (Hypothyroidism on stable treatment is allowed if thyroid stimulating hormone (TSH) measure within the last 3 months of screening is within normal limits).
  • Have had at any time or plan to have endoscopic and/or device-based therapy for obesity including but not limited to the following:
  • Mucosal ablation,
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  • Gastric artery embolization,
  • Intragastric balloon, OR
  • Duodenal-jejunal endoluminal liner
  • Surgery of any kind within 3 months prior to Day 0 (Baseline) with the exception of minor procedures or determined by the Investigator to be clinically relevant for participation in the study, or any planned surgery during the study.
  • Renal impairment as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated at screening using the recommended method for estimating eGFR in adults from the National Kidney Foundation Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) equation (Charles 2024).
  • Acute kidney injury or dialysis within the last 3 months prior to the screening visit
  • Current malignancy with the exception of participants with basal cell carcinoma of this skin, suqamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
  • Positive results at screening that indicate an active virological infection at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus.
  • Previous organ or bone marrow transplant.
  • History and/or confirmed seizure disorder; reports febrile and/or idiopathic seizures occurring within the past 2 years.
  • Unstable cardiovascular disease as determined by the Investigator or medical history of myocardial infarction or arterial thromboembolic events within 3 months prior to screening or severe or unstable angina, NYHA Class III or IV disease, or a 12-lead ECG showing QTc interval (Fridericia's formula) >450 msec (males) or >470 msec (females), any tachyarrhythmia, pathologic Q waves, or any other abnormality deemed clinically significant in the opinion of the investigator.
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participants' participation for the full duration of the study, or is not in the best interest of the participants to participate in the opinion of the Investigator.
  • Have history of any of the following:
  • Major Depressive Disorder (MDD)
  • A lifetime history of suicide attempts
  • Other severe psychiatric disorder(s) (e.g., schizophrenia, bipolar disorder, etc.)
  • Use of anti-depressant medication
  • Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10 at screening and/or Day 0 (Baseline).
  • At screening or Day 0 (Baseline) have any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) or any suicidal behavior in the lifetime or previous month.
  • History or presence of drug abuse (including medicinal and recreational marijuana use) within the 1 year prior to Day 0 (Baseline) or urine drug assay at screening or Day 0 (Baseline) positive (includes: amphetamines, barbiturates, cocaine metabolites, opiates, benzodiazepines, and cannabinoids).
  • Prior exposure to study drugs
  • Nimacimab injection
  • Glucagon-like peptide-1 (GLP-1) agonist.
  • Allergy to active or inactive component of Nimacimab
  • Allergy to active or inactive component(s) of GLP-1 agonist
  • Female participants who are pregnant or breastfeeding or expecting to conceive children within the projected duration of the study.
  • Aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 × upper limit of normal (ULN) at screening. One repeat test may be allowed within 7 days of the receiving the result, at the discretion of the Investigator.
  • Absolute neutrophil count ≤ 1.5 × 109/L.
  • Platelets ≤ 120 × 109/L.
  • Hemoglobin (Hgb) < 13.5 g/dL in males and < 12 g/dL in females.
  • Currently or have participated in a study of an investigational product or used an investigational device within 12 weeks and/or 5 times the half-life of the investigational product prior to the (Day 0, Baseline) first dose of study treatment.
  • Current use of any medication that is known to cause weight loss or participation in a structured weight loss program within the last 6 months prior to screening
  • Employees of the Sponsor, contract research organization (CO) involved in the conduct of the study, or investigational site, or immediate family members of the employees.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer of 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.
  • Study Extension Eligibility Criteria
  • Participants are eligible to be included in the extension only if all the following criteria apply:
  • Completed Week 26 of the Main study including Week 25 on study treatment. Participants who completed Week 26 of the Main study but discontinued study treatment prior to that visit are not eligible to participate.
  • Participants in the combination arms (Nimacimab Injection or placebo + Semaglutide) of the Main study must roll over within 4 weeks of Main study Week 26
  • Participants in the monotherapy arms (Nimacimab Injection or placebo) of the Main study can roll over anytime after they have completed Week 26 on study treatment but before completing the 13-week follow-up period.
  • Does not have any condition that interferes with the ability to complete the Extension in the judgment of the investigator.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Pinnacle Research Group

    Anniston, Alabama, 36207

  • ACCEL Research Sites

    Atlanta, Georgia, 30342

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Lillestol Research, LLC

    Fargo, North Dakota, 58104

  • Center for Advanced Research & Education

    Gainesville, Georgia, 30501

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • Be Well Clinical Studies

    Lincoln, Nebraska, 68516

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Weill Cornell Medicine

    New York, New York, 11375

  • ActivMed Practices & Research

    Portsmouth, New Hampshire, 03801

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Be Well Clinical Studies

    Round Rock, Texas, 78681

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Accellacare of Wilmington

    Wilmington, North Carolina, 28401

Other trials in United States

About this study

Official title: A Phase 2 Study of QW Nimacimab Injection, Compared to Placebo Injection and QW Weekly Nimacimab Injection Co-administered With Semaglutide in Participants Who Are Overweight or Obese

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

Read the detailed description

The purpose of this study is to measure the change in body weight with once weekly doses of Nimacimab Injection compared with placebo injection and once weekly Nimacimab Injection co-administered with commercially available semaglutide injection (Wegovy®) in participants with obesity or are overweight with weight-related comorbidities. A study extension has been added to include additional 26 weeks of treatment and 13 weeks of follow up for qualifying participants starting May2025.

Conditions
Obesity
Being tested
Nimacimab injection, Nimacimab placebo injection, semaglutide injection, Nimacimab 300 mg injection
Keywords
Nimacimab
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nimacimab injectionBiological

    Nimacimab injection 200 mg

  • Nimacimab placebo injectionBiological

    matching nimacimab placebo injection

  • semaglutide injectionCombination product

    semaglutide injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, 2.4 mg + nimacimab 200 mg

  • Nimacimab 300 mg injectionBiological

    Nimacimab injection 300 mg

Study groups in NCT06577090
Study groupRoleWhat they receive
Nimacimab injectionExperimentalNimacimab injection 200 mg
Receives: Biological: Nimacimab injection
Nimacimab placebo injectionPlacebo comparatorMatching nimacimab placebo injection
Receives: Biological: Nimacimab placebo injection
Semaglutide injection + Nimacimab injection 200 mgExperimentalSemaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg
Receives: Biological: Nimacimab injection; Combination Product: semaglutide injection
Semaglutide injection + Nimacimab placebo injectionActive comparatorSemaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection
Receives: Biological: Nimacimab placebo injection; Combination Product: semaglutide injection
Open-label 300 mg Nimacimab injection (study extension)ExperimentalWeekly nimacimab injection 300 mg open-label (study extension)
Receives: Biological: Nimacimab 300 mg injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change in body weight (main study)

    Percent of participants who have a reduction in body weight

    Measured: From Baseline to Week 26

  2. Nature, frequency and severity of AEs (study extension)

    Nature, frequency and severity of treatment-emergent adverse events, including serious adverse events and adverse events of special interest

    Measured: Baseline through Week 38 of study extension (approximately 10 months of participation)

Secondary outcomes (9)

  1. Change in body weight (main study)

    Change in body weight in kg

    Measured: From Baseline to Week 26

  2. Change in waist circumference (main study)

    Change in waist circumference in cm

    Measured: From Baseline to Week 26

  3. Change in waist circumference (study extension)

    Change in waist circumference in cm

    Measured: From baseline to Week 26 of study extension (approximately 7 months of participation)

  4. Change in lean versus fat mass ratio measured by DXA (main study)

    Change in lean versus fat mass ratio measured by DEXA (DXA) scan.

    Measured: From Baseline to Week 26

  5. Change in lean versus fat mass ratio measured by DXA (study extension)

    Change in lean versus fat mass ratio measured by DEXA (DXA) scan.

    Measured: From baseline to Week 26 of study extension (approximately 7 months of participation)

  6. Change in BMI (main study)

    Change in BMI (weight and height will be combined to report BMI in kg/m^2)

    Measured: From Baseline to Week 26

  7. Change in BMI (study extension)

    Change in BMI (weight and height will be combined to report BMI in kg/m^2)

    Measured: From baseline to Week 26 of study extension (approximately 7 months of participation)

  8. Percent of participants with greater than/equal to 5% body weight reduction as well as greater than/equal to 10% body weight reduction (main study)

    Percent of participants with specific body weight reduction (percent based on weight measured in kg)

    Measured: From Baseline to Week 26

  9. Percent change in body weight (kg) (study extension)

    Change in body weight (percent based on weight measured in kg)

    Measured: From baseline to Week 26 of study extension (approximately 7 months of participation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2024
  2. Study start22 Aug 2024
  3. Primary completion20 Nov 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Partially blinded combination arm x 2, blinded monotherapy arm x 2, open-label study extension arm monotherapy x 1.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06577090
Sponsor's protocol ID
SBI-018-201
Acronym
CBeyond
Status last verified
Jan 2026
First submitted
19 Aug 2024
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nimacimab injection, semaglutide injection and Nimacimab 300 mg injection in people with Obesity, run by Skye Bioscience, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent change in body weight (main study) (time frame: From Baseline to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06577090.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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