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Study to Evaluate the Effect on Obesity of QW Nimacimab and QW Nimacimab Co-administered With Semaglutide vs Placebo | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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

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

NCT06577090•Skye Bioscience, Inc.

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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.
•2. 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.
•3. Male, female, and/or nonbinary participants.
•4. Have Body Mass Index (BMI) of
•1. ≥ 30 kg/m2 to ≤ 45 kg/m2 OR
•2. ≥ 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.
+10 more criteria

Exclusion Criteria

•1. Have any prior diagnosis of type 1 or type 2 diabetes mellitus (T1DM or T2DM, or rare forms of diabetes mellitus).
•2. 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).
•3. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \> 1 year prior to screening).
•4. 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).
•5. Have had at any time or plan to have endoscopic and/or device-based therapy for obesity including but not limited to the following:
•1. Mucosal ablation,
•2. Gastric artery embolization,
•3. Intragastric balloon, OR
•4. Duodenal-jejunal endoluminal liner
•6. 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.
+35 more criteria

Locations (16)

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

Key Dates

Start Date

August 22, 2024

Primary Completion Date

November 20, 2026

Completion Date

February 28, 2027

Last Updated

January 14, 2026

Enrollment

136

ACTUAL participants

Conditions

Obesity

Interventions

Nimacimab injection

BIOLOGICAL

Nimacimab placebo injection

BIOLOGICAL

semaglutide injection

COMBINATION_PRODUCT

Nimacimab 300 mg injection

BIOLOGICAL

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NCT07472881

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RECRUITING

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

NCT01143454

Metabolic DiseaseObesity+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

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