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RISE-1

Not yet recruitingPhase 3

Efficacy And Safety of Olatorepatide in Adults With Overweight or Obesity Without Diabetes

A Phase 3, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Participants Living With Overweight or Obesity Without Diabetes (RISE-1)

Asset

Olatorepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

-

Estimated enrollment

3,000

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07896265
Org study IDHS-20094-OB-2570
Secondary ID2025
Secondary ID2025-524861-26-00

Timeline

Milestones

Study first posted2026-10-26actual
Last update posted2026-10-26actual
Study start2026-11-18estimated
Primary completion2028-12-19estimated
Study completion2029-01-23estimated

Assets

Investigational agents

Olatorepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Key Inclusion Criteria:

1. Has BMI ≥30.0 kg/m^2 at screening OR BMI ≥27.0 kg/m^2 at screening with at least 1 of the following weight-related comorbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease, as described in the protocol

2. History of one or more self-reported unsuccessful dietary attempts to lose weight

Key Exclusion Criteria:

1. Have previous or current diagnosis of diabetes, including Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) or screening HbA1c ≥6.5% as described in the protocol

2. Change in body weight >5 kg within 90 days prior to randomization as described in the protocol

3. Current use or previous treatment in 90 days prior to screening with GLP-1-RA, GLP-1/GIP RA, related molecule, or any other Nutrient-Stimulated Hormone (NuSH)-based therapy

4. Current treatment or treatment in 90 days prior to screening associated with weight loss or weight gain or high risk of initiation of such a treatment during the study duration as described in the protocol

5. Previous or planned bariatric surgery

Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Endpoints (28)

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.

Coverage by outcome category

Cardiometabolic biomarkers
10
Weight & body composition
8
Other (unclassified)
4
Safety / tolerability / PK
3
Glycemic / diabetes
2
Renal / kidney
1

Weight & body composition

8 endpoints
Primary/protocol endpoint

Percent change in body weight

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of ≥5% reduction in body weight

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of ≥10% reduction in body weight

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of ≥15% reduction in body weight

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of ≥20% reduction in body weight

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-Lite-Clinical Trials (IWQOL-Lite-CT) Physical Function score

Time frame:From baseline to week 72

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in Hemoglobin A1C (HbA1c)

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:From baseline to week 72

change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Percent change in urine Albumin-Creatinine Ratio (uACR)

Time frame:From baseline to week 72

percent change from baseline, improvement

Cardiometabolic biomarkers

10 endpoints
Secondary/protocol endpoint

Change in Systolic Blood Pressure (SBP)

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Change in Diastolic Blood Pressure (DBP)

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint

Percent change in total cholesterol

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in Low-Density Lipoprotein Cholesterol (LDL-C)

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in High-Density Lipoprotein Cholesterol (HDL-C)

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in non-HDL-C

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in Very-Low-Density Lipoprotein Cholesterol (VLDL-C)

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in triglycerides

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in Apolipoprotein B (ApoB)

Time frame:From baseline to week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Percent change in high-sensitivity C-Reactive Protein (hs-CRP)

Time frame:From baseline to week 72

percent change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Occurrence of Anti-Drug Antibody (ADA) to olatorepatide

Time frame:Up to approximately 72 weeks

descriptive

Secondary/protocol endpoint

Magnitude of ADA to olatorepatide

Time frame:Up to approximately 72 weeks

descriptive

Secondary/protocol endpoint

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:Up to approximately 76 weeks

descriptive

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Change in IWQOL-Lite-CT Physical Composite score

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in IWQOL-Lite-CT Total score

Time frame:From baseline to week 72

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Concentrations of olatorepatide in plasma

Time frame:Up to approximately 76 weeks

concentration, descriptive

Secondary/protocol endpoint/low confidence

Occurrence of Neutralizing Antibody (NAb) to olatorepatide

Time frame:Up to approximately 72 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.