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

NCT06577090 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SBI-018-201
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Obesity

Keywords

Nimacimab

Outcome Measures

Primary Outcomes (2)

• Percent change in body weight (main study)

  Percent of participants who have a reduction in body weight

  From Baseline to Week 26

• 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

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

Secondary Outcomes (9)

• Change in body weight (main study)

  From Baseline to Week 26

• Change in waist circumference (main study)

  From Baseline to Week 26

• Change in waist circumference (study extension)

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

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

  From Baseline to Week 26

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

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

Study Arms (5)

Nimacimab injection

EXPERIMENTAL

Nimacimab injection 200 mg

Biological: Nimacimab injection

Nimacimab placebo injection

PLACEBO COMPARATOR

Matching nimacimab placebo injection

Biological: Nimacimab placebo injection

Semaglutide injection + Nimacimab injection 200 mg

EXPERIMENTAL

Semaglutide injection administered according to dose escalation described in semaglutide prescribing information plus concomitant administration of Nimacimab Injection 200 mg

Biological: Nimacimab injection; Combination Product: semaglutide injection

Semaglutide injection + Nimacimab placebo injection

ACTIVE COMPARATOR

Semaglutide injection administered according to dose escalation described in semaglutide Prescribing Information plus concomitant administration of Nimacimab Injection or matching placebo injection

Biological: Nimacimab placebo injection; Combination Product: semaglutide injection

Open-label 300 mg Nimacimab injection (study extension)

EXPERIMENTAL

Weekly nimacimab injection 300 mg open-label (study extension)

Biological: Nimacimab 300 mg injection

Interventions

Nimacimab injection BIOLOGICAL

Nimacimab injection 200 mg

Nimacimab injection; Semaglutide injection + Nimacimab injection 200 mg

Nimacimab placebo injection BIOLOGICAL

matching nimacimab placebo injection

Nimacimab placebo injection; Semaglutide injection + Nimacimab placebo injection

semaglutide injection COMBINATION_PRODUCT

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

Semaglutide injection + Nimacimab injection 200 mg; Semaglutide injection + Nimacimab placebo injection

Nimacimab 300 mg injection BIOLOGICAL

Nimacimab injection 300 mg

Open-label 300 mg Nimacimab injection (study extension)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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.

Sponsors & Collaborators

• Skye Bioscience, Inc.: lead

Study Sites (16)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Chase Medical Research, LLC

Waterbury, Connecticut, 06708, United States

Location

ACCEL Research Sites

Atlanta, Georgia, 30342, United States

Location

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Be Well Clinical Studies

Lincoln, Nebraska, 68516, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

ActivMed Practices & Research

Portsmouth, New Hampshire, 03801, United States

Location

Weill Cornell Medicine

New York, New York, 11375, United States

Location

Accellacare of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Lillestol Research, LLC

Fargo, North Dakota, 58104, United States

Location

Velocity Clinical Research, Dallas

Dallas, Texas, 75230, United States

Location

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

semaglutide; Injections

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chief Development Officer

  Skye Bioscience, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants assigned to combination arms will be masked to IP/placebo assignment but unmasked to Wegovy assignment. Participants in the monotherapy arms will remain masked to IP/placebo treatment assignment. Participants who enroll in the study extension (monotherapy arms) will be enrolled into an open-label unblinded 300 mg nimacimab treatment arm. Participants who enroll in the study extension (combination arms) will remain blinded to their treatment assignments with the exception of their Wegovy dose as in the main study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partially blinded combination arm x 2, blinded monotherapy arm x 2, open-label study extension arm monotherapy x 1.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 29, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (16)