DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06893016

RecruitingPhase 3

Evaluation of RAY1225 in Adult Participants Who Have Obesity or Are Overweight

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study Evaluating the Safety, Tolerability, and Efficacy of RAY1225 in Participants Who Have Obesity or Are Overweight

Asset

RAY1225

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

640

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoints

•Body Weight•≥ 5% Reduction in Body Weight

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06893016
Org study IDRAY1225-24-07

Timeline

Milestones

Study first posted2025-03-25actual
Study start2025-06-15actual
Last update posted2025-07-17actual
Primary completion2026-06-15estimated
Study completion2026-09-15estimated

Assets

Investigational agents

RAY1225

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Age ≥ 18 years.

2. Body mass index ≥ 28 kg/m2 or ≥24kg/m² to <28 kg/m2 with at least 1 of the following weight-related comorbidities:

a)Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or the use of at least one antihypertensive medication to maintain normal blood pressure;b) Fasting triglycerides (TG) ≥1.70 mmol/L, fasting low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, fasting high-density lipoprotein cholesterol (HDL-C) <1.04 mmol/L, or the need for at least one lipid-lowering treatment to maintain normal lipid levels;
c)Obstructive sleep apnea syndrome;
d)Fatty liver;
e)Cardiovascular disease;
e)Polycystic ovary syndrome.

3. History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion criteria

1. Obesity known to be caused by monogenic mutations, other diseases, or medications.

2. Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.

3. A history of moderate to severe depression at any time in the past or a score of ≥15 on the PHQ-9 questionnaire at screening; a history of bipolar disorder, schizophrenia, or other severe psychiatric disorders.

4. A history of organ transplantation (excluding corneal transplant), or being currently prepared to undergo organ transplantation.

5. Plans to quit smoking during the study period

6. Allergic constitution (allergic to multiple medications or foods), or those known to be allergic to RAY1225, GLP-1 receptor agonists, or GLP-1 related drugs.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

3 endpoints
Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 52

Time frame:Baseline and Week 52

percent change from baseline, improvement

Primary/protocol endpoint

Number of Participants who Achieved a ≥ 5% Reduction in Body Weight from Baseline at Week 52

Time frame:Baseline and Week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 52

Time frame:Baseline and Week 52

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.