A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity (INLIGHT)

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in two adult populations: Pre Type 2 diabetes (Pre T2D) and Type 2 Diabetes (T2D) in adults who are affected by obesity.

Study Overview

• Status: Recruiting
• Conditions: Overweight and Obesity
• Intervention / Treatment: Drug: WVE-007

• Study Type: Interventional
• Enrollment (Estimated): 296
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Operations; Phone Number: 855-215-4687; Email: Clinicaltrials@wavelifesci.com

Study Locations

• Moldova
  • Chisinau, Moldova, MD-2025
    • Recruiting
    • ARENSIA Research Clinic
    • Contact: Maxim Bogus; Phone Number: 373 78883374; Email: Maxim.bogus@arensia-em.com
• Romania
  • Bucharest, Romania, 011658
    • Recruiting
    • Arensia Clinics S.R.L.
    • Contact: Simona Macovei; Phone Number: +40711912918; Email: simona.macovei@arensia-em.com
  • Cluj-Napoca, Romania, 400006
    • Recruiting
    • Spitalul Clinic Judetean de Urgenta Cluj
    • Contact: Emanuela Beni; Phone Number: +40711912839; Email: emanuela.beni@arensia-em.com
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Recruiting
    • Parexel International Early Phase Clinical Unit
    • Contact: Pablo Forte; Phone Number: 01895 614 890; Email: Pablo.ForteSoto@parexel.com
  • Merthyr Tydfil, United Kingdom, CF48 4DR
    • Recruiting
    • Simbec-Orion Clinical Pharmacology
    • Contact: Annelize Koch; Phone Number: 01685 700870; Email: Annelize.koch@simbecorion.com
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Recruiting
      • Parexel International-EPCU Baltimore
      • Contact: Ronald Goldwater, M.D.; Phone Number: 877-617-8839; Email: study.baltimore@parexel.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Part A

• Male and female participants aged 18 to 60 years
• BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 will be allowed.
• Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments

Inclusion Criteria : Part B

• Male and female participants aged 18 to 60 years
• BMI 35 to 50 kg/m2 (inclusive)
• Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days
• Have Pre T2D or T2D

Exclusion Criteria: Part A

• History or presence of CV disease, including heart failure (New York Heart Association [NYHA] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments
• History or presence of thyroid disorders
• Medical history or diagnosis of causes of liver disease
• Use of any siRNA agent in the prior 12 months
• Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study

Exclusion Criteria: Part B

• History of significant CV disease in the opinion of the Investigator.
• Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 7 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and statins.
• Taking >2 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
• Taking >1 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
• Cohorts 1 and 2 (preT2D) only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
• Cohorts 4 and 5 (T2D) only: use of insulin or any medication that directly stimulates pancreatic insulin within the 60 days prior to Screening, including sulfonylureas, meglitinides, GLP-1 receptor agonists, dual incretin agonists, and DPP-4 inhibitors.
• Use of any siRNA agent in the prior 12 months.
• Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo	Drug: WVE-007; Stereopure siRNA oligonucleotide
Experimental: Cohort 2; Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo	Drug: WVE-007; Stereopure siRNA oligonucleotide
Experimental: Cohort 3; Part A: Experimental WVE-007 (Dose 3) or Placebo	Drug: WVE-007; Stereopure siRNA oligonucleotide
Experimental: Cohort 4; Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo	Drug: WVE-007; Stereopure siRNA oligonucleotide
Experimental: Cohort 5; Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo	Drug: WVE-007; Stereopure siRNA oligonucleotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of participants with adverse events	Day 1 through end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration of WVE-007 in plasma (Cmax)	Part A:Day 1 through 169 Part B: Day 1 through 253
Area under the plasma concentration time curve for WVE-007 from time 0 to last measurable concentration (AUClast)	Part A:Day 1 through 169 Part B: Day 1 through 253
Change over time from baseline levels of serum activin E	Part A:Day 1 through 169 Part B: Day 1 through 337

Other Outcome Measures

Outcome Measure	Time Frame
Percent change of weight (kg) from baseline	Day 1 through 169 Part B: Day 1 through 337
Body composition changes as follows: Change in body fat percentage from baseline, percent change of visceral fat (kg) from baseline, and percent change in fat-free mass (kg) from baseline	Part A: Day 1 through 169 Part B: Day 1 through 337

Collaborators and Investigators

• Sponsor: Wave Life Sciences USA, Inc.
• Investigators: Study Director: Medical Director, MD, Wave Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 29, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: WVE-007-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No