PPDTM CorEvitasTM Obesity (OBR) Drug Effectiveness and Safety Registry

The design is an open-ended prospective observational (non-interventional) registry for subjects living with excess weight or obesity under the care of a qualified provider with documented experience treating patients with obesity

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity
• Intervention / Treatment: Other: Biospecimen collection

Detailed Description

The objective of the registry is to create a cohort of subjects living with excess weight or obesity to evaluate long-term real-world effectiveness and safety of standard of care treatments for obesity. Data collected through the registry may be used to address a range of research questions and use cases, including but not limited to: characterizing the natural history of the disease, evaluating the effectiveness and safety of commercially available medications for the treatment of obesity, providing information to support ongoing risk-benefit evaluation by drug manufacturers and regulators, and research related to drug utilization, disease burden, and unmet needs.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • CorEvitas, LLC

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Subjects enrolled in this registry will be treated according to routine clinical care; the assignment of subjects to any treatment will not be determined in advance by the protocol and will be clearly separated from the decision to include subjects in the registry

Description

Inclusion Criteria:

To be eligible to participate in this registry, an individual must meet all of the following criteria:

1. In the opinion of the investigator, the subject is considered a suitable candidate for treatment with a commercially available systemic obesity medication (see Enrollment Eligible Treatments). While subjects do not need to start an obesity medication at the time of registry enrollment, those prescribed a GLP-based or non-GLP-based obesity medication must be initiating the medication for the first time.
2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable laws of the jurisdiction in which the research is being conducted at the time of enrollment.
3. Is willing and able to consent to participation in the registry.
4. Is willing and able to complete registry-related forms electronically via personal devices
5. Is willing and able to provide first name, last name, email address, language, and primary time zone for electronic data collection account creation.
6. For US subjects only, is willing and able to provide Personally Identifiable Information which includes full legal name, sex at birth, date of birth, and home address zip code.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in the registry:

1. Has Type 2 diabetes (T2D).
2. Is participating or planning to participate in a blinded clinical trial.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obesity Epidemiology and presentation	The major clinical outcome include an assessment of the epidemiology of Obesity. This will be determined using PROs and ClinROs which will be included as part of the case report forms.	Every 6 months for 10 years

Collaborators and Investigators

• Sponsor: CorEvitas

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2025
• Primary Completion (Estimated): December 31, 2099
• Study Completion (Estimated): December 31, 2099

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: CorEvitas-OBR-300

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No