A Phase 3 interventional study of Petrelintide and Placebo in Obesity or Overweight and Cardiovascular Disease, sponsored by Hoffmann-La Roche. Recruiting at 3 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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Among 21 studies in Obesity by Hoffmann-La Roche — 8 open to participants now, 12 under way, 7 of them phase 3. Obesity · Hoffmann-La Roche.
Among the 21 studies in Obesity by Hoffmann-La Roche, this one is the 3rd largest by planned enrollment, is one of 8 that started in 2026, is one of 8 in phase 3, reaches primary completion later than 10 of the 11 other live ones, and was the 20th registered.
11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.
Browse Obesity studies →8 of the 21 studies in Obesity by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States
Ages 18+
Hoffmann-La Roche · Sites in United States
Ages 18+
Hoffmann-La Roche · Sites in China
Ages 18+
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 19 more countries
Ages 18+
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 18 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 2,500 is above the median of 67 across 9,016 interventional studies indexed under Obesity.
Median enrollment 300 across the 21 interventional studies. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
3 of the studies in Obesity by Hoffmann-La Roche that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06982131Hoffmann-La RocheA Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants | 2026-12-07 |
| NCT07499050Hoffmann-La RocheA Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight | 2027-01-09 |
| NCT07589686Hoffmann-La RocheA Dose-Finding Study of Petrelintide With Enicepatide (RO7795068) in Adults With Obesity or Overweight | 2027-11-12 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies in Obesity by Hoffmann-La Roche, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and established cardiovascular disease (CVD).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: Petrelintide
Combination Product: Placebo
Petrelintide will be administered subcutaneously (SC) using a drug-device combination product.
Also known as: RO7895515, ZP8396
Petrelintide-matching placebo will be administered SC using a drug-device combination product.
Percentage Change in Body Weight from Baseline
Time frame: From Baseline to Week 64
Proportion of Participants Achieving ≥ 5% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Proportion of Participants Achieving ≥ 10% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Proportion of Participants Achieving ≥ 15% Body Weight Loss from Baseline
Time frame: From Baseline to Week 64
Change from Baseline in Waist Circumference (cm)
Time frame: From Baseline to Week 64
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: From Baseline to Week 64
Change from Baseline in Triglycerides
Time frame: From Baseline to Week 64
Change from Baseline in High-Density Lipoprotein (HDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQoL-Lite-CT) Physical Functioning Composite Score
Time frame: From Baseline to Week 64
Change from Baseline in IWQoL-Lite-CT Physical Functioning Composite Score in Participants with Poor Physical Functioning at Baseline (as defined by Patient Global Impression of Severity/Status [PGI-S])
Time frame: From Baseline to Week 64
Change from Baseline in Short Form (36) Health Survey Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame: From Baseline to Week 64
Change from Baseline in SF-36v2 Acute Form Physical Functioning Domain Score in Participants with Poor Physical Functioning at Baseline (as defined by PGI-S)
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Food Craving Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Peak Hunger Score
Time frame: From Baseline to Week 64
Change from Baseline in Body Mass Index (BMI) (kg/m²)
Time frame: From Baseline to Week 64
Change from Baseline in Body Weight (kg)
Time frame: From Baseline to Week 64
Change from Baseline in Waist-to-Hip Ratio
Time frame: From Baseline to Week 64
Change from Baseline in Waist-to-Height Ratio
Time frame: From Baseline to Week 64
Change from Baseline in Fasting Insulin
Time frame: From Baseline to Week 64
Change from Baseline in Fasting Glucose
Time frame: From Baseline to Week 64
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: From Baseline to Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 5.7%
Time frame: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 6.5%
Time frame: At Week 64
Percentage of Participants with Type 2 Diabetes at Screening Achieving HbA1c of < 7%
Time frame: At Week 64
Percentage of Participants With Baseline Prediabetes Achieving HbA1c of < 5.7%
Time frame: At Week 64
Change from Baseline in Very-Low-Density Lipoprotein (VLDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Non-HDL Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Total Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Low-Density Lipoprotein (LDL) Cholesterol
Time frame: From Baseline to Week 64
Change from Baseline in Free Fatty Acids
Time frame: From Baseline to Week 64
Change from Baseline in Systolic Blood Pressure
Time frame: From Baseline to Week 64
Change from Baseline in Diastolic Blood Pressure
Time frame: From Baseline to Week 64
Change from Baseline in Health-Related Quality of Life (HRQoL) as assessed by SF-36v2 Acute Form Domain Scores and Component Summary Scores
Time frame: From Baseline to Week 64
Change from Baseline in HRQoL as assessed by IWQoL-Lite-CT Domain Scores and Total Score
Time frame: From Baseline to Week 64
Proportion of Participants with ≥ 14.6-Point Increase from Baseline in IWQoL-Lite-CT Physical Function Score
Time frame: From Baseline to Week 64
Proportion of Participants with ≥ 3.7-Point Increase from Baseline in SF36v2 Physical Functioning Score
Time frame: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving ≥ 14.6-Point Increase in IWQoL-Lite-CT Physical Functioning Score
Time frame: From Baseline to Week 64
Proportion of Participants with Baseline Poor Physical Functioning Achieving a ≥ 3.7-Point Increase in SF36v2 Physical Functioning Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Hunger Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Satiety Score
Time frame: From Baseline to Week 64
Change from Baseline in Mean Daily Average Appetite Score
Time frame: From Baseline to Week 64
Incidence and Severity of Adverse Events, with Severity Determined According to Mild/Moderate/Severe Criteria
Time frame: From Baseline to Week 64
Percentage of Participants with Baseline Anti-Drug Antibodies (ADAs) and Treatment-Emergent ADAs Against Petrelintide
Time frame: From Baseline to Week 64
Started Sep 2026 (actual). Primary completion is estimated for Jul 2030, 45 months after the start.
Of 199 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 45 months is above that.
Counting every sponsor, half of 262 studies reached it within 24 months; a quarter within 18 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Petrelintide