Type 2 Diabetes (T2D) Clinical Trials

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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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

Locations
United States
Maryland
Parexel International-EPCU Baltimore
RECRUITING
Baltimore
Other Locations
Republic of Moldova
ARENSIA Research Clinic
RECRUITING
Chisinau
Romania
Arensia Clinics S.R.L.
RECRUITING
Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
RECRUITING
Cluj-napoca
United Kingdom
Parexel International Early Phase Clinical Unit
RECRUITING
Harrow
Simbec-Orion Clinical Pharmacology
RECRUITING
Merthyr Tydfil
Contact Information
Primary
Clinical Operations
Clinicaltrials@wavelifesci.com
855-215-4687
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2027-12
Participants
Target number of participants: 296
Treatments
Experimental: Cohort 1
Part A: Experimental WVE-007 (Dose 1) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 1) or Placebo
Experimental: Cohort 2
Part A: Experimental WVE-007 (Dose 2) or Placebo Part B Pre-T2D: Experimental WVE-007 (Dose 2) or Placebo
Experimental: Cohort 3
Part A: Experimental WVE-007 (Dose 3) or Placebo
Experimental: Cohort 4
Part A: Experimental WVE-007 (Dose 4) or Placebo Part B T2D: Experimental WVE-007 (Dose 4) or Placebo
Experimental: Cohort 5
Part A: Experimental WVE-007 (Dose 5) or Placebo Part B T2D: Experimental WVE-007 (Dose 5) or Placebo
Related Therapeutic Areas
Sponsors
Leads: Wave Life Sciences USA, Inc.

This content was sourced from clinicaltrials.gov