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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

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

Key facts

Study ID

NCT06577090

Run by

Skye Bioscience, Inc.

People needed

136

Starts

2024-08-22

Expected to finish

2027-02-28

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• i. 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.
• ii. cardiovascular disease: (for example, ischemic cardiovascular disease, New York Heart Association [NYHA] Functional Classification Class I-II heart failure).
• iii. obstructive sleep apnea syndrome (Salzano 2021).
• iv. 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.

You may not qualify if…

• 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,
• 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.

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Chase Medical Research, LLC — Waterbury, Connecticut, United States
• ACCEL Research Sites — Atlanta, Georgia, United States
• Center for Advanced Research & Education — Gainesville, Georgia, United States
• L-MARC Research Center — Louisville, Kentucky, United States
• Be Well Clinical Studies — Lincoln, Nebraska, United States
• Palm Research Center — Las Vegas, Nevada, United States
• ActivMed Practices & Research — Portsmouth, New Hampshire, United States
• Weill Cornell Medicine — New York, New York, United States
• Accellacare of Wilmington — Wilmington, North Carolina, United States
• Lillestol Research, LLC — Fargo, North Dakota, United States
• Velocity Clinical Research, Dallas — Dallas, Texas, United States
• Be Well Clinical Studies — Round Rock, Texas, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States
• Rainier Clinical Research Center — Renton, Washington, United States

Full record on ClinicalTrials.gov

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