A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults

NCT07465965 | Recruiting Phase 1 FDA Drug

• 1 other identifier: WL1006-US-I-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this study is to examine the Safety, Tolerability and Pharmacokinetic of Semaglutide Nasal Spray compared with placebo and positive control in Adult Overweight or Obese Participants.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (36)

• Maximum Plasma Concentration (Cmax)

  Day 1 to Day 36 after administration

• Time to maximum concentration(Tmax)

  Day 1 to Day 36 after administration

• Area under the concentration-time curve from time 0 to time t (AUC0-t)

  Day 1 to Day 36 after administration

• Area under the concentration-time curve from time 0 to infinity(AUC0-∞)

  Day 1 to Day 36 after administration

• Percentage of AUC extrapolated(AUC%Extrap)

  Day 1 to Day 36 after administration

• Elimination half-life / Terminal half-life(t1/2)

  Day 1 to Day 36 after administration

• Apparent volume of distribution during terminal phase, adjusted for bioavailability (Vz/F)

  Day 1 to Day 36 after administration

• Apparent clearance, adjusted for bioavailability(CL/F)

  Day 1 to Day 36 after administration

• Terminal elimination rate constant(λz)

  Day 1 to Day 36 after administration

• Absolute bioavailability(F)

  Day 1 to Day 36 after administration

• Incidence and severity of treatment emergent adverse events (TEAEs)

  Day 1 to Day 36 after administration

• 12-Lead-ECGs(Electrocardiograms )

  Day 1 to Day 36 after administration

• Temperature

  Day 1 to Day 36 after administration

• Pulse

  Day 1 to Day 36 after administration

• Respiratory rate

  Day 1 to Day 36 after administration

• Blood pressure

  Day 1 to Day 36 after administration

• Urinalysis

  Day 1 to Day 36 after administration

• Blood biochemistry

  Alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin, γ-glutamyl transferase, alkaline phosphatase, total protein, albumin, urea, uric acid, creatinine, calcium, chloride, potassium, sodium, phosphorus, total cholesterol, triglycerides, fasting blood glucose, creatine kinase, lactate dehydrogenase, amylase, lipase.

  Day 1 to Day 36 after administration

• Thyroid function

  Thyroid-stimulating hormone, total tri-iodothyronine, total thyroxine, free tri-iodothyronine, free thyroxine

  Day 1 to Day 36 after administration

• Virology test

  Day 1 to Day 36 after administration

• Urine pregnancy test

  Day 1 to Day 36 after administration

• Physical examination, includes: head, ears, eyes, nose and throat, skin, lymph nodes, neck, chest, abdomen, heart, cardiovascular, musculoskeletal system/extremities, neurological system and body weight.

  Day 1 to Day 4 after administration

• Hemoglobin

  Day 1 to Day 36 after administration

• Hematocrit

  Day 1 to Day 36 after administration

• Red blood cell count

  Day 1 to day 36

• White blood cell count

  Day 1 to day36

• Platelet count

  Day 1 to day 36

• Neutrophil percentage

  day 1 to day 36

• Eosinophil percentage

  day 1 to day 36

• Basophil percentage

  day 1 to day 36

• Monocyte percentage

  day 1 to day 36

• Lymphocyte percentage

  day 1 to day 36

• Activated partial thromboplastin time

  Day 1 to day 36

• Prothrombin time

  day 1 to day 36

• Fibrinogen

  day 1 to day 36

• Thrombin time

  day 1 to day 36

Secondary Outcomes (4)

• Positive rate of Anti-Drug Antibody (ADA)

  Day 1 to Day 29 after administration

• Titer of Anti-Drug Antibody (ADA)

  Day 1 to Day 29 after administration

• Positive rate of Neutralizing antibody (Nab)

  Day 1 to Day 29 after administration

• Titer of Neutralizing antibody (Nab)

  Day 1 to Day 29 after administration

Study Arms (4)

Cohort A0 : Semaglutide Nasal Spray

EXPERIMENTAL

Drug: Semaglutide Nasal Spray

Cohort A1: Semaglutide nasal spray and placebo

EXPERIMENTAL

Drug: Semaglutide Nasal Spray; Drug: Placebo

Cohort A2:Semaglutide nasal spray and placebo

EXPERIMENTAL

Drug: Semaglutide Nasal Spray; Drug: Placebo

Cohort A3: Semaglutide injection

ACTIVE COMPARATOR

Drug: Semaglutide Injection

Interventions

Semaglutide Nasal Spray DRUG

WL1006

Cohort A0 : Semaglutide Nasal Spray; Cohort A1: Semaglutide nasal spray and placebo; Cohort A2:Semaglutide nasal spray and placebo

Placebo DRUG

WL1006

Cohort A1: Semaglutide nasal spray and placebo; Cohort A2:Semaglutide nasal spray and placebo

Semaglutide Injection DRUG

Wegovy®

Cohort A3: Semaglutide injection

Eligibility Criteria

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

You may qualify if:

• Male or female participants aged ≥18 years and ≤ 65 years.
• Body Mass Index (BMI) at screening between 27.0 and 35.0 kg/m² (inclusive).
• Weight change of no more than ±5% during the 3 months prior to screening with diet and exercise alone (self-reported).
• Participants (including males) must have no plans for conception during the study and within 3 months after the last administration, and must agree to use effective contraceptive methods and refrain from donating sperm or eggs during this period.
• Negative anti-HIV antibody test result at screening.
• Participants must fully understand the trial objectives, nature, procedures, and potential adverse reactions, voluntarily participate, be able to communicate well with the investigators, comply with all study requirements, and sign the informed consent form before any study procedures begin.

You may not qualify if:

• Diagnosis of type 1, type 2, or other forms of diabetes mellitus.
• Prior diagnosis of obesity caused by monogenic mutations or other medical conditions, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism.
• Prior history of bariatric surgery (excluding participants who had liposuction, abdominoplasty, intragastric balloon removal, or duodenal-jejunal bypass sleeve removal \>1 year prior), or plan to undergo bariatric surgery or use weight-loss devices during the study.
• Use of any of the following treatments within 3 months prior to screening:
• Approved or unapproved anti-obesity medications (e.g., liraglutide, semaglutide, benaglutide, tirzepatide, orlistat, phentermine/topiramate, naltrexone/bupropion), or herbal supplements, health products, meal replacements, or weight-loss capsules that may affect body weight;
• Any glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1 related multi-agonists (e.g., GLP-1/glucose-dependent insulinotropic polypeptide \[GIP\] dual agonists, GLP-1/glucagon \[GCG\] dual agonists, GLP-1/GIP/GCG triple agonists), or combination preparations containing GLP-1 receptor agonists;
• Any antidiabetic medications (e.g., odium-glucose cotransporter-2 inhibitors (SGLT2) inhibitors, metformin, alpha-glucosidase inhibitors, insulin);
• Any other treatments known to affect body weight (e.g., cause weight loss or weight gain), including:
• Systemic corticosteroid therapy (intravenous or oral) for \>1 week
• Tricyclic antidepressants (e.g., imipramine, amitriptyline, doxepin)
• Selective serotonin reuptake inhibitors (SSRIs) (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine)
• Antipsychotics/antiepileptics (e.g., imipramine, amitriptyline, mirtazapine, phenelzine, chlorpromazine HCl, clozapine, olanzapine, valproate derivatives, lithium preparations, thioridazine)
• Antihistamines (e.g., cyproheptadine, ketotifen, astemizole).
• Any investigational drugs, vaccines, or medical devices.
• Laboratory abnormalities at screening meeting any of the following:

Sponsors & Collaborators

• Shanghai World Leader Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Frontage Clinical Services, Inc.

Secaucus, New Jersey, 07094, United States

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guiyi Huang, Master

CONTACT

0086-18640027113; huangguiyi@worldleadertdds.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: March 12, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)