> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/efficacy-and-safety-of-ribupatide-administered-once-weekly-45d86a3e-3a40-45e4-87eb-be4b574d95cd
> Record changed: 2026-10-13

# Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

NCT07284979

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Participants

1,200

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Lead sponsor

Kailera

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Start date

2025-12-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

Number of sites

53

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Title and summary

**Summary**

The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Acronym**

KaiNETIC-3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Short title**

Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Official title**

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Dates

**Completion date**

2028-04-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**First posted**

2025-12-16

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Registry last updated**

2026-07-22

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Primary completion date**

2028-03-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Start date**

2025-12-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Size and sites

**Participants**

1,200

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Planned participants**

1,200

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Number of sites**

53

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Lead sponsor**

Kailera

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Identifiers

**Registry ID**

NCT07284979

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**ClinicalTrials.gov ID**

NCT07284979

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Treatment

**Masking**

Double masking

**Masking description**

The participant and investigator will be blinded for participants randomized to ribupatide or placebo until the study is complete. Semaglutide will be provided open label.

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Outcomes

### Primary outcomes

1. Percent Change From Baseline in Body Weight at Week 76  
Timeframe: Baseline, Week 76

### Secondary outcomes

1. Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight  
Timeframe: Baseline, Week 76
2. Change From Baseline in Waist Circumference  
Timeframe: Baseline, Week 76
3. Change From Baseline in Absolute Body Weight  
Timeframe: Baseline, Week 76
4. Percentage of Participants with ≥5% Reduction in Body Weight  
Timeframe: Baseline, Week 76
5. Change From Baseline in Systolic Blood Pressure (SBP)  
Timeframe: Baseline, Week 76
6. Percent Change From Baseline in Fasting Triglycerides  
Timeframe: Baseline, Week 76
7. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol  
Timeframe: Baseline, Week 76
8. Percent Change From Baseline in Fasting Non-HDL-cholesterol  
Timeframe: Baseline, Week 76
9. Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score  
Timeframe: Baseline, Week 76
10. Percentage of Participants with ≥30% Reduction in Body Weight  
Timeframe: Baseline, Week 76
11. Change From Baseline in Body Mass Index (BMI)  
Timeframe: Baseline, Week 76
12. Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score  
Timeframe: Baseline, Week 76
13. Change From Baseline in CoEQ Positive Mood Score  
Timeframe: Baseline, Week 76
14. Change From Baseline in CoEQ Craving for Sweets Score  
Timeframe: Baseline, Week 76
15. Change From Baseline in CoEQ Craving for Savory Food Score  
Timeframe: Baseline, Week 76
16. Change From Baseline in CoEQ Hunger Score  
Timeframe: Baseline, Week 76
17. Change From Baseline in CoEQ Satiety Score  
Timeframe: Baseline, Week 76
18. Change From Baseline in CoEQ Combined Score  
Timeframe: Baseline, Week 76
19. Change From Baseline in Food Noise Questionnaire (FNQ) Score  
Timeframe: Baseline, Week 76
20. Number of Participants With Treatment-emergent Adverse Events (TEAEs)  
Timeframe: Day 1 up to Week 80
21. Number of Participants With Anti-drug Antibodies (ADAs)  
Timeframe: Up to Week 80
22. Number of Participants With Neutralizing Antibodies (Nabs)  
Timeframe: Up to Week 80
23. Plasma Concentrations of Ribupatide  
Timeframe: Up to Week 76

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

Key Inclusion Criteria:

- BMI ≥35 kilograms per square meter (kg/m^2).
- History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.

Key Exclusion Criteria:

- Current diagnosis or history of diabetes mellitus.
- Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease.
- History of chronic or acute pancreatitis.
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Sites

- Kailera Clinical SiteGlendale, United StatesRecruiting
- Kailera Clinical SitePhoenix, United StatesRecruiting
- Kailera Clinical SiteLittle Rock, United StatesRecruiting
- Kailera Clinical SiteNorthridge, United StatesRecruiting
- Kailera Clinical SiteOceanside, United StatesRecruiting
- Kailera Clinical SiteHamden, United StatesRecruiting
- Kailera Clinical SiteStamford, United StatesRecruiting
- Kailera Clinical SiteOrange City, United StatesRecruiting
- Kailera Clinical SiteAlbany, United StatesRecruiting
- Kailera Clinical SiteChicago, United StatesRecruiting
- Kailera Clinical SiteSkokie, United StatesRecruiting
- Kailera Clinical SiteNewton, United StatesRecruiting
- Kailera Clinical SiteShreveport, United StatesRecruiting
- Kailera Clinical SiteFarmington Hills, United StatesRecruiting
- Kailera Clinical SiteMissoula, United StatesRecruiting
- Kailera Clinical SiteLas Vegas, United StatesRecruiting
- Kailera Clinical SiteAlbany, United StatesRecruiting
- Kailera Clinical SiteMorehead City, United StatesRecruiting
- Kailera Clinical SiteMorrisville, United StatesRecruiting
- Kailera Clinical SiteNorman, United StatesRecruiting
- Kailera Clinical SiteEast Greenwich, United StatesRecruiting
- Kailera Clinical SiteNorth Charleston, United StatesRecruiting
- Kailera Clinical SiteSpartanburg, United StatesRecruiting
- Kailera Clinical SiteBrownsville, United StatesRecruiting
- Kailera Clinical SiteSan Antonio, United StatesRecruiting

And 28 more, listed on the interactive page.

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## References

### Other registry identifiers (2)

- 2025
- 2025-523511-11-00

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284979)

## Related records

### Drugs (1)

- [Semaglutide](https://trialight.com/data/asset/semaglutide-0f0980aa-d386-4209-8f14-80da83c40d80.md)

### Lead sponsors (1)

- [Kailera](https://trialight.com/data/company/kailera-9089bfa7-3191-422a-ab0b-b9af6a9e395b.md)

### Conditions (1)

- [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition

### Targets (1)

- [GLP1R](https://trialight.com/data/target/glp1r-c31cc749-2d8a-54a9-9dab-84f5ee5d1742.md)

---

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