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

NCT06842186 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: WVE-007-001
• Study Type: interventional
• Target: 296
• Locations: 4 countries
• Sites: 6

Brief Summary

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.

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with adverse events

  Day 1 through end of study

Secondary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (5)

Cohort 1

EXPERIMENTAL

Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo

Drug: WVE-007

Cohort 2

EXPERIMENTAL

Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo

Drug: WVE-007

Cohort 3

EXPERIMENTAL

Part A: Experimental WVE-007 (Dose 3) or Placebo

Drug: WVE-007

Cohort 4

EXPERIMENTAL

Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo

Drug: WVE-007

Cohort 5

EXPERIMENTAL

Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo

Drug: WVE-007

Interventions

WVE-007 DRUG

Stereopure siRNA oligonucleotide

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Wave Life Sciences USA, Inc.: lead

Study Sites (6)

Parexel International-EPCU Baltimore

Baltimore, Maryland, 21225, United States

RECRUITING

ARENSIA Research Clinic

Chisinau, MD-2025, Moldova

RECRUITING

Arensia Clinics S.R.L.

Bucharest, 011658, Romania

RECRUITING

Spitalul Clinic Judetean De Urgenta Cluj

Cluj-Napoca, 400006, Romania

RECRUITING

Parexel International Early Phase Clinical Unit

Harrow, HA1 3UJ, United Kingdom

RECRUITING

Simbec-Orion Clinical Pharmacology

Merthyr Tydfil, CF48 4DR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director, MD

  Wave Life Sciences

  STUDY DIRECTOR

Central Study Contacts

Clinical Operations

CONTACT

855-215-4687; Clinicaltrials@wavelifesci.com

Study Design

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

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 24, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1); US (1); RO (2); GB (2)