Obesity evidence dossier

KAI-7535

An oral GLP-1 option with Phase 3 Chinese obesity data, while global dose/titration optimization remains in Phase 2.

Kailera Therapeutics; Hengrui Pharma develops HRS-7535 in Greater ChinaPhase 3 completed in China; global Phase 2 ongoingOral, once daily

Weight loss score /10039

Comparison statusOther trial data · Includes treatment stops

EvidencePhase 3 · Sponsor disclosure

Follow-up44 weeks

Total weight loss

9.8%

HARBOR-1 · 180 mg daily · week 44 · Includes treatment stops

Placebo-adjusted

7.4%

Difference from placebo in the same study when reported.

Study context

Once-daily oral small-molecule GLP-1 receptor agonist/Adults with obesity or overweight in China/Not verified in this source/44-week endpoint

Baseline: See the source for enrollment criteria

Ranked result & calculation

HARBOR-1 · 180 mg daily · 44 weeks

Adults with obesity or overweight in China. Study size not verified in the cited disclosure.

Includes treatment stops. Treatment-policy results estimate outcomes regardless of stopping treatment.

Average weight loss: 9.8%
Placebo group: 2.4% loss
Beyond placebo: 7.4 percentage points (arm subtraction)
Stopped due to adverse events: 3.1% treatment / 2.7% placebo

Week 44 primary result. The ad hoc week 50 analysis is not substituted.

Score: 70% × 39.2 total-loss points + 30% × 37.0 beyond-placebo points = 39/100, rounded. Conversion scales

Alternative analysis assuming continued treatment: 10.9% total loss. This is not the result used for the headline score. Alternative analysis source ↗

Kailera, HARBOR-1 ↗Phase 3 · Sponsor disclosure · Reviewed 2026-09-21

Evidence

Benchmark read

HARBOR-1: Includes treatment stops. Week 44 primary result. The ad hoc week 50 analysis is not substituted.

Safety

Side effects and cautions

Discontinuation read

Stopped because of adverse events: 3.1% on treatment vs 2.7% on placebo.

Common side effects

Most treatment-emergent adverse events reported by Kailera were mild-to-moderate and gastrointestinal-related.

Main cautions

Investigational outside any applicable local regulatory authorization; global efficacy and safety results are pending. GLP-1-class gastrointestinal tolerability and titration are important considerations.

Upcoming catalyst

What to watch next

Global Phase 2 data expected in 2027.

Linked clinical trials

Trials in the saddl3 obesity snapshot

Non-diabetic obesity studies are prioritized; diabetes and healthy-volunteer studies remain visible and labeled.

NCT06904105

Phase 3

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

Shandong Suncadia Medicine Co., Ltd.

Non-diabetic obesity

Active

Jun 22, 2025

NCT06820099

Phase 2

Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity

Shandong Suncadia Medicine Co., Ltd.

Non-diabetic obesity

Recruiting

Dec 29, 2025

NCT07497880

Phase 2

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Kailera

Non-diabetic obesity

Not yet recruiting

Mar 27, 2026

NCT07269756