Obesity or OverweightPhase 2NCT07081958

A Study Evaluating the Effect of Daily Oral RO7795081 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

A Phase 2 study testing RO7795081 in people with Obesity or Overweight, run by Hoffmann-La Roche at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding, Phase II study aims to evaluate the efficacy, tolerability, and safety of RO7795081 for chronic weight management in adult participants with obesity or overweight with at least one weight-related comorbidity, but… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Obesity or Overweight
What is being tested?: RO7795081
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 352 participants
Where: 36 sitesUnited States
Study dates: 29 Jul 2025to 30 Jul 2026
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must have at screening:
Body mass index (BMI) greater than or equal to (≥)30.0 kg/m^2; or
BMI ≥27.0 kg/m^2 and <30.0 kg/m^2 with at least one weight-related comorbidity, such as hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, cardiovascular disease
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)

Who cannot join

Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes [T1D], T2D, or rare forms of diabetes)
Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
Prior or planned surgical treatment for obesity
Have a known, clinically significant gastric emptying abnormality
Have poorly controlled hypertension, untreated renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension

Show all 9Show fewer

Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.
Have a history of acute or chronic pancreatitis
Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder), or had a suicide attempt within the last 1 year of screening

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Accellacare of McFarland
Ames, Iowa, 50010
Pinnacle Research Group
Anniston, Alabama, 36207
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731
Apex Mobile Clinical Research
Bellaire, Texas, 77401
Internal Medicine and Pediatrics Associates of Bristol
Bristol, Tennessee, 37620
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Accellacare of Cary - Cary Medical Group
Cary, North Carolina, 27518
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
K2 Medical Research-Winter Garden
Clermont, Florida, 34711
Velocity Clinical Research
Dallas, Texas, 75230
Accellacare - Hickory
Hickory, North Carolina, 28601
Juno Research, LLC
Houston, Texas, 77040
Alliance for Multispecialty Research. LLC
Knoxville, Tennessee, 37909
Accellacare of Knoxville
Knoxville, Tennessee, 37912
Knoxville-Summit-Halls Family Practice
Knoxville, Tennessee, 37938
Orange County Research Center
Lake Forest, California, 92630
K2 Medical Research-Maitland
Maitland, Florida, 32751
Manassas Clinical Research Center
Manassas, Virginia, 20110
Clinical Research Associates
Nashville, Tennessee, 37203
Alliance for Multispecialty Research, LLC (AMR Norman)
Norman, Oklahoma, 73069
Accellacare of Duly Health and Care
Oak Lawn, Illinois, 60453
Tristar Clinical Investigations
Philadelphia, Pennsylvania, 19114
Accellacare of Raleigh
Raleigh, North Carolina, 27609
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
Accellacare of Rocky Mount
Rocky Mount, North Carolina, 27804
Accellacare of Salisbury
Salisbury, North Carolina, 28144
Consano Clinical Research
Shavano Park, Texas, 78231
Asclepes Research Centers
Sherman Oaks, California, 91403
Encompass Clinical Research
Spring Valley, California, 91978
Chrysalis Clinical Research
St. George, Utah, 84790
Accellacare of Piedmont Healthcare
Statesville, North Carolina, 28625
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291
Emerson Clinical Research Institute LLC
Washington D.C., District of Columbia, 20009
Chase Medical Research
Waterbury, Connecticut, 06708-3346
Accellacare of Wilmington, LLC
Wilmington, North Carolina, 28401
Accellacare Research of Winston Salem
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity

Conditions: Obesity or Overweight
Being tested: RO7795081, Placebo
Medical subject headings: Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RO7795081Drug
Also called CT-996, RG6652
RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.
PlaceboDrug
Placebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.

Study groups in NCT07081958
Study group	Role	What they receive
Arm 1: Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Arm 2: RO7795081 Dosing Regimen 1	Experimental	Not described Receives: Drug: RO7795081
Arm 3: RO7795081 Dosing Regimen 2	Experimental	Not described Receives: Drug: RO7795081
Arm 4: RO7795081 Dosing Regimen 3	Experimental	Not described Receives: Drug: RO7795081
Arm 5: RO7795081 Dosing Regimen 4	Experimental	Not described Receives: Drug: RO7795081
Arm 6: RO7795081 Dosing Regimen 5	Experimental	Not described Receives: Drug: RO7795081
Arm 7: RO7795081 Dosing Regimen 6	Experimental	Not described Receives: Drug: RO7795081
Arm 8: RO7795081 Dosing Regimen 7	Experimental	Not described Receives: Drug: RO7795081

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Change in Body Weight From Baseline to Week 30
Measured: Baseline to Week 30

Secondary outcomes (11)

Absolute Change in Body Weight (kg) from Baseline to Week 30
Measured: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline to Week 38
Measured: Baseline to Week 38
Percent Change in Body Weight From Baseline to Week 38
Measured: Baseline to Week 38
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30
Measured: Baseline and Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38
Measured: Baseline and Week 38
Absolute Change in BMI (kg/m^2) from Baseline to Week 30
Measured: Baseline to Week 30
Absolute Change in BMI (kg/m^2) from Baseline to Week 38
Measured: Baseline to Week 38
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)
Measured: From first dose until 28 days after the final dose of study treatment (42 weeks)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42
The C-SSRS is an assessment tool to evaluate suicidal ideation and behavior during the assessment period via a participant-reported questionnaire comprising 2 to 6 questions (yes or no). Affirmative responses count as 1 point, which are then summed to indicate the level of suicide risk on a scale of 0 (no risk) to 6 (high risk).
Measured: Baseline to Week 42
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42
PHQ-9 is a 9-item patient reported outcome (PRO) used to assess severity of depression. Responses are rated based on the frequency of symptoms on a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day). A PHQ-9 total score ranging from 0 to 27 can be calculated by summing the nine items; a higher score corresponds with more severe depression.
Measured: Baseline to Week 42
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Measured: Predose on Day 1 and at prespecified timepoints until Week 38

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jul 202530 Jul 2026

First posted24 Jul 2025
Study start29 Jul 2025
Primary completion28 Apr 2026
Study completion30 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity or OverweightStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07081958
Sponsor's protocol ID: BP45702
Status last verified: Oct 2026
First submitted: 22 Jul 2025
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight

All Obesity or Overweight trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of Once-Daily RO7795081 Administered for 38 Weeks to Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity
ClinicalTrials.gov ID: NCT07081958
Acronym / sponsor ID: BP45702
Conditions: Obesity or Overweight
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 29 Jul 2025 (actual)
Primary completion: 28 Apr 2026 (actual)
Study completion: 30 Jul 2026 (actual)
First posted: 24 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Arm 1: Placebo	Placebo comparator	Drug: Placebo
Arm 2: RO7795081 Dosing Regimen 1	Experimental	Drug: RO7795081
Arm 3: RO7795081 Dosing Regimen 2	Experimental	Drug: RO7795081
Arm 4: RO7795081 Dosing Regimen 3	Experimental	Drug: RO7795081
Arm 5: RO7795081 Dosing Regimen 4	Experimental	Drug: RO7795081
Arm 6: RO7795081 Dosing Regimen 5	Experimental	Drug: RO7795081
Arm 7: RO7795081 Dosing Regimen 6	Experimental	Drug: RO7795081
Arm 8: RO7795081 Dosing Regimen 7	Experimental	Drug: RO7795081

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participants must have at screening:
History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight
A stable body weight for the 3 months prior to screening (maximum 5% body weight gain and/or loss)

Key exclusion criteria (9 listed)

Have a history or diagnosis of any type of diabetes mellitus (Type 1 diabetes [T1D], T2D, or rare forms of diabetes)
Have obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin-4 receptor deficiency or Prader-Willi Syndrome)
Participation in unbalanced/extreme diets or in an organized weight reduction program within 3 months of the screening visit or planning to engage in such diets or programs during the study
Prior or planned surgical treatment for obesity
Have a known, clinically significant gastric emptying abnormality

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RO7795081Also: CT-996, RG6652RO7795081 will be administered orally once daily, according to the randomized dosing regimen, during the 38-week treatment period.	Drug	Arm 2: RO7795081 Dosing Regimen 1, Arm 3: RO7795081 Dosing Regimen 2, Arm 4: RO7795081 Dosing Regimen 3, Arm 5: RO7795081 Dosing Regimen 4, Arm 6: RO7795081 Dosing Regimen 5, Arm 7: RO7795081 Dosing Regimen 6, Arm 8: RO7795081 Dosing Regimen 7
PlaceboPlacebo matching each RO7795081 dosing regimen arm will be administered orally once daily during the 38-week treatment period.	Drug	Arm 1: Placebo

Primary outcome

Percent Change in Body Weight From Baseline to Week 30
Time frame: Baseline to Week 30

11 secondary outcomes

Absolute Change in Body Weight (kg) from Baseline to Week 30
Time frame: Baseline to Week 30
Absolute Change in Body Weight (kg) from Baseline to Week 38
Time frame: Baseline to Week 38
Percent Change in Body Weight From Baseline to Week 38
Time frame: Baseline to Week 38
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 30
Time frame: Baseline and Week 30
Percentage of Participants Who Achieve ≥5%, ≥10%, ≥15%, or ≥20% Body Weight Reduction from Baseline at Week 38
Time frame: Baseline and Week 38
Absolute Change in BMI (kg/m^2) from Baseline to Week 30
Time frame: Baseline to Week 30
Absolute Change in BMI (kg/m^2) from Baseline to Week 38
Time frame: Baseline to Week 38
Incidence of Adverse Events (AEs), Adverse Events of Special Interest (AESIs), and Serious AEs (SAEs)
Time frame: From first dose until 28 days after the final dose of study treatment (42 weeks)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores from Baseline to Week 42
Time frame: Baseline to Week 42
Change in Patient Health Questionnaire-9 (PHQ-9) Scores from Baseline to Week 42
Time frame: Baseline to Week 42
Plasma Concentrations of RO7795081 at Prespecified Timepoints
Time frame: Predose on Day 1 and at prespecified timepoints until Week 38

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Related trials for Obesity or Overweight

Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 3
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Obesity or Overweight
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
RecruitingPhase 2
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or Obesity
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

36 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO7795081 in people with Obesity or Overweight, run by Hoffmann-La Roche at 36 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Weight From Baseline to Week 30 (time frame: Baseline to Week 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07081958.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.