Testing WVE-007 for adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and tolerability of WVE-007, administered subcutaneously in single ascending doses, in adults living with overweight or obesity. Participants will be monitored for pharmacokinetics and pharmacodynamics to understand how the drug behaves in the body. The study aims to include healthy adults aged 18 to 60 with a stable BMI between 28 and 35 kg/m2. Exclusion criteria include significant cardiovascular or thyroid conditions and recent use of investigational agents.

Why it matters

Who can join: the full rules

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 75 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
* Participants with or without Type 2 Diabetes (T2D and non-T2D, respectively)

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 5 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and lipid lowering medications.
* Taking \>3 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.
* Taking \>2 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.
* Cohorts 1 and 2 only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.
* Cohorts 4 to 7 only: use of sulfonylurea and meglitinides within 60 days prior to Screening and insulin, GLP-1 receptor agonist, and dual incretin agonist within 90 days prior to Screening
* Cohorts 6 and 7 only: Known serious hypersensitivity to tirzepatide or any excipients
* Diagnosis of Type 1 diabetes mellitus, or dependence on daily or ongoing use of insulin or insulin analogs for glycemic control.
* 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.

Where it's running

• Parexel International-EPCU Baltimore
  Baltimore, Maryland, United States Recruiting
• ARENSIA Research Clinic
  Chisinau, Moldova Recruiting
• Arensia Clinics S.R.L.
  Bucharest, Romania Recruiting
• Spitalul Clinic Judetean De Urgenta Cluj
  Cluj-Napoca, Romania Recruiting
• Parexel International Early Phase Clinical Unit
  Harrow, United Kingdom Recruiting
• Simbec-Orion Clinical Pharmacology
  Merthyr Tydfil, United Kingdom Recruiting

Study contacts

• Study coordinator: Clinical Operations
• Email: Clinicaltrials@wavelifesci.com
• Phone: 855-215-4687

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nutrition support to improve dietary diversity in adults who are underweight or overweight/obese

  A community-based nutrition program will be tested in adults in Cambodia to see if it improves dietary diversity and if the program is acceptable and feasible to run.

  Recruiting National University of Singapore · Phnom Penh, Phnom Penh · NCT07836322

• Hesperidin for better thinking in overweight older adults

  In adults aged 55–75 who are overweight, taking hesperidin or a placebo for 10 weeks will show whether the citrus flavonoid can improve thinking skills like memory, attention, and problem-solving.

  Recruiting University of Glasgow · Shanghai, Shanghai Municipality · NCT07750223

• MR-based performance tests for overweight and obesity

  This study tests mixed reality versions of mobility tests to see if they match conventional assessments in adults who are overweight or obese.

  Recruiting Selcuk University · Konya, Selcuklu · NCT07654439

• DA-302168S in adults with overweight or obesity

  A phase 3 trial in China is testing whether DA-302168S helps people who are overweight or obese lose weight compared with a placebo.

  Recruiting Phase 3 Chendu DIAO Pharmaceutical Group CO., LTD. · Beijing · NCT07629544

• Metabolic Health Trajectories in Overweight Chinese Adults

  This observational study follows overweight and obese Chinese adults to see how metabolic health changes over five years and whether people stay healthy, develop diabetes, or have complications.

  Recruiting Zhujiang Hospital · Guangzhou, Guangdong · NCT07584330

• Blood-count inflammation scores (SII and SIRI) to predict metabolic complications in adults with overweight or obesity

  This project will test whether two blood-count-based scores (SII and SIRI) can help predict metabolic complications and treatment response in adults with overweight or obesity.

  Recruiting University of Rijeka · Varaždin · NCT07431593

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.